Advanced Recurrent Ovarian Tumors, Advanced Solid Tumors
Conditions
Keywords
Advanced solid tumors, Advanced recurrent ovarian tumors, MEDI3617, Ang2, Ovarian cancer, Malignant glioma
Brief summary
To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.
Interventions
DRUGMEDI3617
Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.
DRUGBevacizumab
Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.
DRUGPaclitaxel
Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.
DRUGCarboplatin
Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.
Sponsors
MedImmune LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy exists * Patients must be 18 years of age or older * Karnofsky Performance Status ≥ 70 * Toxicities from previous cancer therapies must have recovered to CTCAE Grade = or \< 2 * Adequate organ and marrow function * Using adequate contraceptive measures, be surgically sterile or post-menopausal
Exclusion criteria
* Concurrently enrolled in another clinical study, except for non-interventiona observational studies, or if in a follow up period from a previous study * Receipt of any investigational anticancer therapy within 30 days prior to the first dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days prior to the first dose of MEDI3617 * Current or previous treatment with angiopoietin inhibitors, or inhibitors of Tie1 or Tie2 including, but not limited to, AMG386, CVX-060, XL880, and XL820 * Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment * Use of immunosuppressive medication or systemic steroids within 7 days prior to first dose of MEDI3617 * Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results * Known bleeding diathesis * Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment * Therapeutic or palliative radiation therapy within 2 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1) | DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617. |
| Maximum Tolerated Dose (MTD) | From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1) | The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From start of study drug administration up to 90 days after the last dose of MEDI3617 | An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events occurring after administration of investigational product. |
| Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | From start of study drug administration up to 90 days after the last dose of MEDI3617 | Laboratory evaluations were performed, including hematology and serum chemistry. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to laboratory abnormalities were recorded and reported. |
| Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | From start of study drug administration up to 90 days after the last dose of MEDI3617 | Vital signs included parameters such as heart rate, blood pressure, temperature, weight and respiratory rate. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to vital signs abnormalities were recorded and reported. |
| Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs) | From start of study drug administration up to 90 days after the last dose of MEDI3617 | An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to echocardiogram abnormalities were recorded and reported. The only AE reported was ejection fraction decreased in the MEDI3617 + Paclitaxel total group. |
| Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs) | From start of study drug administration up to 90 days after the last dose of MEDI3617 | An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to electrocardiogram abnormalities were recorded and reported. The only AE reported was electrocardiogram QT prolonged in the MEDI3617 + Bevacizumab Q2W total group. |
| Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline | From start of study drug administration up to 30 days after the last dose of MEDI3617 | KPS scale: 100 is no evidence of disease; 90 is able to carry on normal activity, minor symptoms of disease; 80 is normal activity with effort, some symptoms of disease; 70 is cares for self; unable to do active work; 60 is requires occasional assistance, but is able to care for most of his needs; 50 is requires considerable assistance with frequent medical care; 40 is disabled, requires special care; 30 is severely disabled, hospitalization is indicated although death is not imminent; 20 is very sick, hospitalization necessary, active support treatment necessary; 10 is moribund, fatal processes progressing rapidly, 0 is dead. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Time from the first dose of investigational product until end of study | Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method. |
| Time to Progression (TTP) | Time from the first dose of investigational product until end of study | Time to progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP was evaluated using the Kaplan-Meier method. |
| Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose | Cmax is the maximum observed serum concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose. |
| Overall Survival (OS) | Time from the first dose of investigational product until death due to any cause | Overall survival is defined as the time from the start of treatment with MEDI3617 until death. For the participants who were alive at the end of study or lost to follow-up, overall survival was censored on the last date when participants were known to be alive. Overall survival was evaluated using the Kaplan-Meier method. |
| Circulating Levels of Angiopoietin 2 (Ang2) | Prior to infusion on Cycle 4 and Cycle 5 | Profile of Ang2 post MEDI3617 administration in relation to time course of antibody concentrations. |
| Progression-Free Survival (PFS) | Time from the first dose of investigational product until end of study | PFS was measured from the start of treatment with MEDI3617 until the documentation of disease progression or death due to any cause, whichever occurred first. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had PFS censored on the first date of treatment with MEDI3617. PFS was evaluated using the Kaplan-Meier method. |
| Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose | AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose. |
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose | The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose. |
| Systemic Clearance (CL) of MEDI3617 | Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose | Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). Here, n is number of participants analyzed for this endpoint at a specific dose. |
| Terminal Elimination Half Life (t1/2) of MEDI3617 | Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose | The t1/2 is the time in days required for the concentration of the drug to reach half of its original value. Here, n is number of participants analyzed for this endpoint at a specific dose. |
| Number of Participants With Positive Anti-Drug Antibody (ADA) | Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617 | The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays. |
| Objective Response Rate (ORR) | Time from the first dose of investigational product until end of study | Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be 0 if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Time to Response (TTR) | Time from the first dose of investigational product until end of study | Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be 0 if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated using the Kaplan-Meier method. |
Countries
United States
Participant flow
Pre-assignment details
A total of 162 participants were screened, of which 46 did not meet eligibility criteria and were considered as screen failures; the remaining 116 participants entered into the study and treated with MEDI3617.
Participants by arm
| Arm | Count |
|---|---|
| MEDI3617 SINGLE AGENT TOTAL Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days. | 42 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days. | 16 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days. | 38 |
| MEDI3617 + PACLITAXEL TOTAL Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days. | 13 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days. | 7 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Alternative Therapy | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Alternative Therapy. | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 22 | 7 | 21 | 6 | 2 |
| Overall Study | Entered Hospice And Refused Follow Up | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lesion In ThoracicSpine Requires Therapy | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 2 | 1 | 0 |
| Overall Study | Palliative Radiation To Brain Metastases | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Participant Went To Hospice | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Per Sponsor Request o Discontinue Drug | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Pi Decision Due To Declining Status | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Pi Discretion Due To Hospitalisation | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 11 | 3 | 1 |
Baseline characteristics
| Characteristic | Total | MEDI3617 SINGLE AGENT TOTAL | MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | MEDI3617 + BEVACIZUMAB Q2W TOTAL | MEDI3617 + PACLITAXEL TOTAL | MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL |
|---|---|---|---|---|---|---|
| Age, Continuous | 59.2 Years STANDARD_DEVIATION 11.9 | 61.4 Years STANDARD_DEVIATION 12.4 | 57.4 Years STANDARD_DEVIATION 11.9 | 57.7 Years STANDARD_DEVIATION 11.2 | 60.4 Years STANDARD_DEVIATION 12.7 | 56.7 Years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 65 Participants | 27 Participants | 7 Participants | 18 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 51 Participants | 15 Participants | 9 Participants | 20 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 40 / 42 | 16 / 16 | 34 / 38 | 13 / 13 | 7 / 7 |
| serious Total, serious adverse events | 18 / 42 | 4 / 16 | 18 / 38 | 7 / 13 | 4 / 7 |
Outcome results
Primary
Maximum Tolerated Dose (MTD)
The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
Time frame: From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
Population: DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Maximum Tolerated Dose (MTD) | NA milligram (mg) |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Tolerated Dose (MTD) | NA milligram (mg) |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Tolerated Dose (MTD) | NA milligram (mg) |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Tolerated Dose (MTD) | NA milligram (mg) |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Tolerated Dose (MTD) | NA milligram (mg) |
Primary
Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline
KPS scale: 100 is no evidence of disease; 90 is able to carry on normal activity, minor symptoms of disease; 80 is normal activity with effort, some symptoms of disease; 70 is cares for self; unable to do active work; 60 is requires occasional assistance, but is able to care for most of his needs; 50 is requires considerable assistance with frequent medical care; 40 is disabled, requires special care; 30 is severely disabled, hospitalization is indicated although death is not imminent; 20 is very sick, hospitalization necessary, active support treatment necessary; 10 is moribund, fatal processes progressing rapidly, 0 is dead.
Time frame: From start of study drug administration up to 30 days after the last dose of MEDI3617
Population: Safety population included all participants who received treatment with MEDI3617
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline | 11 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline | 6 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline | 7 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline | 1 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline | 1 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
Time frame: From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
Population: DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Dose Limiting Toxicities (DLTs) | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Dose Limiting Toxicities (DLTs) | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Dose Limiting Toxicities (DLTs) | 2 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Dose Limiting Toxicities (DLTs) | 1 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Dose Limiting Toxicities (DLTs) | 1 Participants |
Primary
Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to echocardiogram abnormalities were recorded and reported. The only AE reported was ejection fraction decreased in the MEDI3617 + Paclitaxel total group.
Time frame: From start of study drug administration up to 90 days after the last dose of MEDI3617
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs) | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs) | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs) | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs) | 1 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs) | 0 Participants |
Primary
Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to electrocardiogram abnormalities were recorded and reported. The only AE reported was electrocardiogram QT prolonged in the MEDI3617 + Bevacizumab Q2W total group.
Time frame: From start of study drug administration up to 90 days after the last dose of MEDI3617
Population: Safety population included all participants who received treatment with MEDI3617
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs) | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs) | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs) | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs) | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs) | 0 Participants |
Primary
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
Laboratory evaluations were performed, including hematology and serum chemistry. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to laboratory abnormalities were recorded and reported.
Time frame: From start of study drug administration up to 90 days after the last dose of MEDI3617
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Aspartate aminotransferase increased | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Leukopenia | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Neutropenia | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Thombocytopenia | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: White blood cell count decreased | 2 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Alanine aminotransferase increased | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Anemia | 5 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood alkaline phosphatase increased | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood creatinine increased | 2 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood lactate dehydrogenase increased | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood potassium increased | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood triglycerides increased | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood urea increased | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Gamma-glutamyltransferase increased | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperglycaemia | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperkalaemia | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypertriglyceridaemia | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperuricaemia | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoalbuminaemia | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypocalcaemia | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoglycaemia | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypokalaemia | 3 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypomagnesaemia | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyponatremia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Anemia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoglycaemia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypokalaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood potassium increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperuricaemia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Aspartate aminotransferase increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Neutropenia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypocalcaemia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood triglycerides increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood creatinine increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoalbuminaemia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypomagnesaemia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Alanine aminotransferase increased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood urea increased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypertriglyceridaemia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: White blood cell count decreased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Leukopenia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Thombocytopenia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Gamma-glutamyltransferase increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperkalaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood lactate dehydrogenase increased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyponatremia | 2 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood alkaline phosphatase increased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperglycaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypocalcaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood alkaline phosphatase increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperkalaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypomagnesaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypertriglyceridaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoalbuminaemia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Thombocytopenia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperuricaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood creatinine increased | 2 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: White blood cell count decreased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyponatremia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood lactate dehydrogenase increased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoglycaemia | 2 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Neutropenia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood potassium increased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypokalaemia | 2 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood triglycerides increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Aspartate aminotransferase increased | 2 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Leukopenia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood urea increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperglycaemia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Gamma-glutamyltransferase increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Alanine aminotransferase increased | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Anemia | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: White blood cell count decreased | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Alanine aminotransferase increased | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Aspartate aminotransferase increased | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoglycaemia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood alkaline phosphatase increased | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood creatinine increased | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood lactate dehydrogenase increased | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood potassium increased | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood triglycerides increased | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypokalaemia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood urea increased | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Gamma-glutamyltransferase increased | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyponatremia | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperglycaemia | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperkalaemia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypertriglyceridaemia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypomagnesaemia | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperuricaemia | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoalbuminaemia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Anemia | 3 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Leukopenia | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypocalcaemia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Neutropenia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Thombocytopenia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperkalaemia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperglycaemia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Gamma-glutamyltransferase increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Thombocytopenia | 2 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Anemia | 2 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypokalaemia | 1 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood urea increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood triglycerides increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood alkaline phosphatase increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Leukopenia | 2 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Aspartate aminotransferase increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood potassium increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood lactate dehydrogenase increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Alanine aminotransferase increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: Neutropenia | 3 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypocalcaemia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Blood creatinine increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoglycaemia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypomagnesaemia | 3 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyperuricaemia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypertriglyceridaemia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | Hematology: White blood cell count decreased | 1 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hypoalbuminaemia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs) | SerChem: Hyponatremia | 2 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events occurring after administration of investigational product.
Time frame: From start of study drug administration up to 90 days after the last dose of MEDI3617
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 42 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 18 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 16 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 4 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 38 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 18 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 7 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 13 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TEAEs | 7 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | TESAEs | 4 Participants |
Primary
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Vital signs included parameters such as heart rate, blood pressure, temperature, weight and respiratory rate. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to vital signs abnormalities were recorded and reported.
Time frame: From start of study drug administration up to 90 days after the last dose of MEDI3617
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Tachycardia | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Arrhythmia | 1 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Sinus tachycardia | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Pyrexia | 3 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight decreased | 0 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight increased | 9 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypertension | 10 Participants |
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypotension | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypertension | 7 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Tachycardia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Arrhythmia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Pyrexia | 3 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Sinus tachycardia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypotension | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight decreased | 2 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight increased | 2 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight increased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Pyrexia | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Sinus tachycardia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight decreased | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Tachycardia | 0 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypotension | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypertension | 13 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Arrhythmia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Arrhythmia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Sinus tachycardia | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Pyrexia | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight increased | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Tachycardia | 1 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypotension | 0 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypertension | 3 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight decreased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Arrhythmia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Sinus tachycardia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Tachycardia | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypotension | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Pyrexia | 1 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight decreased | 1 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Weight increased | 0 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs) | Hypertension | 2 Participants |
Secondary
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose.
Time frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
Population: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP1 (n=3) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 4 (n=2) | 2150 day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort -2 (n=1) | 1.79 day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 1 (n=1) | 8.12 day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 2 (n=2) | 269 day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4B (n=1) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 5 (n=2) | 4230 day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP1 (n=1) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1A (n=3) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4A (n=2) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 3B (n=2) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE -1 (n=12) | 3280 day*mcg/mL | Standard Deviation 1410 |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP2 (n=1) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 3 (n=3) | 529 day*mcg/mL | Standard Deviation 269 |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2A (n=3) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2B (n=3) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE 1 (n=2) | 2490 day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP2 (n=2) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1B (n=7) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP1 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1A (n=3) | 110 day*mcg/mL | Standard Deviation 58.1 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4A (n=2) | 3920 day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2A (n=3) | 628 day*mcg/mL | Standard Deviation 376 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 2 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP2 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP2 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 3 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP1 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 4 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4B (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 5 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 1 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 3B (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE -1 (n=12) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort -2 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2B (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE 1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1B (n=7) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort -2 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 1 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 2 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 3 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 4 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 5 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE -1 (n=12) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE 1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4A (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1B (n=7) | 104 day*mcg/mL | Standard Deviation 61 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2B (n=3) | 252 day*mcg/mL | Standard Deviation 83.2 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 3B (n=2) | 1200 day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4B (n=1) | 4630 day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP1 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP2 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP1 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP2 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE 1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1B (n=7) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE -1 (n=12) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP1 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2B (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 5 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 3B (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 4 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4B (n=1) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 3 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort -2 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP1 (n=3) | 849 day*mcg/mL | Standard Deviation 163 |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 2 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP2 (n=1) | 2810 day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 1 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4A (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP2 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 1 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4A (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1B (n=7) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE -1 (n=12) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP1 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 2 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 2B (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 5 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 1A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP1 (n=1) | 2240 day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MCP2 (n=2) | 3560 day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 3B (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 4 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort OCE 1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort -2 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MP2 (n=1) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort MB 4B (n=1) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617 | Cohort 3 (n=3) | NA day*mcg/mL | — |
Secondary
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose.
Time frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
Population: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3A (n=3) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1A (n=4) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP1 (n=4) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4A (n=6) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2A (n=3) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 1 (n=6) | 11.9 day*mcg/mL | Standard Deviation 11.8 |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1B (n=7) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP2 (n=6) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 2 (n=3) | 171 day*mcg/mL | Standard Deviation 69 |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP1 (n=7) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 3 (n=3) | 438 day*mcg/mL | Standard Deviation 204 |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -1 (n=2) | 2.2 day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort TT2A (n=9) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 4 (n=3) | 2610 day*mcg/mL | Standard Deviation 1570 |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4B (n=8) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 5 (n=4) | 3650 day*mcg/mL | Standard Deviation 2600 |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3B (n=8) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE -1 (n=15) | 2610 day*mcg/mL | Standard Deviation 891 |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2B (n=3) | NA day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE 1 (n=2) | 2160 day*mcg/mL | — |
| MEDI3617 SINGLE AGENT TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -2 (n=3) | 1.3 day*mcg/mL | Standard Deviation 0.429 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE 1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort TT2A (n=9) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1A (n=4) | 101 day*mcg/mL | Standard Deviation 48.8 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1B (n=7) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4A (n=6) | 2710 day*mcg/mL | Standard Deviation 1070 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE -1 (n=15) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 4 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2A (n=3) | 473 day*mcg/mL | Standard Deviation 223 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3A (n=3) | 2280 day*mcg/mL | Standard Deviation 529 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4B (n=8) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 1 (n=6) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP2 (n=6) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP1 (n=4) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2B (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 5 (n=4) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP1 (n=7) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3B (n=8) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 3 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE 1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 1 (n=6) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 3 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 4 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 5 (n=4) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE -1 (n=15) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1A (n=4) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4A (n=6) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1B (n=7) | 94.7 day*mcg/mL | Standard Deviation 48.7 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2B (n=3) | 216 day*mcg/mL | Standard Deviation 61.8 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3B (n=8) | 805 day*mcg/mL | Standard Deviation 292 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4B (n=8) | 2310 day*mcg/mL | Standard Deviation 941 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort TT2A (n=9) | 2590 day*mcg/mL | Standard Deviation 1920 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP1 (n=7) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP2 (n=6) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP1 (n=4) | NA day*mcg/mL | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 5 (n=4) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1B (n=7) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE -1 (n=15) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2B (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE 1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP1 (n=4) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3B (n=8) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 4 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4B (n=8) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 3 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort TT2A (n=9) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP1 (n=7) | 551 day*mcg/mL | Standard Deviation 331 |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 1 (n=6) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP2 (n=6) | 1460 day*mcg/mL | Standard Deviation 484 |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1A (n=4) | NA day*mcg/mL | — |
| MEDI3617 + PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4A (n=6) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort TT2A (n=9) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 2 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1B (n=7) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE -1 (n=15) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP2 (n=6) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort OCE 1 (n=2) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2B (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 5 (n=4) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MP1 (n=7) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 1 (n=6) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 1A (n=4) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 3B (n=8) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 4 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP2 (n=3) | 2890 day*mcg/mL | Standard Deviation 257 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MCP1 (n=4) | 1240 day*mcg/mL | Standard Deviation 882 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4A (n=6) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 4B (n=8) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort 3 (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort MB 2A (n=3) | NA day*mcg/mL | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617 | Cohort -2 (n=3) | NA day*mcg/mL | — |
Secondary
Circulating Levels of Angiopoietin 2 (Ang2)
Profile of Ang2 post MEDI3617 administration in relation to time course of antibody concentrations.
Time frame: Prior to infusion on Cycle 4 and Cycle 5
Population: All participants who received treatment with MEDI3617 and for whom PD blood samples were collected and evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort OCE -1 (n=3) | 206.43 nanogram per millileter (ng/mL) | Standard Deviation 83.74 |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 3 (n=1) | 341.21 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort OCE -1 (n=3) | 312.27 nanogram per millileter (ng/mL) | Standard Deviation 151.19 |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 5 (n=1) | 1451.43 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 5 (n=1) | 1181.14 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 3 (n=1) | 265.86 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP1 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 4 (n=1) | 288.10 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -1 (n=2) | 5.11 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MCP1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4B (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4:Cohort MB 3B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 1 (n=3) | 5.69 nanogram per millileter (ng/mL) | Standard Deviation 4.02 |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MP2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1B (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 1 (n=2) | 8.22 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -2 (n=2) | 4.07 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4A (n=4) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 3A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 2 (n=1) | 307.53 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort -2 (n=2) | 4.28 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 3A (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2A (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 2 (n=1) | 924.66 nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MCP1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 SINGLE AGENT TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort -2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 2 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 2 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 3 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 3 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 4 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 5 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 5 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort OCE -1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort OCE -1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1A (n=2) | 386.13 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1A (n=2) | 421.74 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2A (n=3) | 215.71 nanogram per millileter (ng/mL) | Standard Deviation 143.16 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2A (n=2) | 228.92 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 3A (n=1) | 218.48 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 3A (n=2) | 247.51 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4A (n=4) | 368.08 nanogram per millileter (ng/mL) | Standard Deviation 257.59 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4A (n=2) | 353.73 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1B (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4:Cohort MB 3B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4B (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP1 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MP2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MCP1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MCP1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4A (n=4) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 5 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4:Cohort MB 3B (n=1) | 141.93 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MP2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP1 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MCP1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2B (n=1) | 387.45 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1B (n=2) | 466.27 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2A (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2B (n=1) | 421.03 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1B (n=1) | 750.61 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 5 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort OCE -1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort OCE -1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 2 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 2 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 4 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 3A (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 3 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 3 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4B (n=1) | 174.65 nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4B (n=3) | 229.19 nanogram per millileter (ng/mL) | Standard Deviation 109.02 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 3A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort -2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MCP1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 3 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 2 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2A (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 2 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP2 (n=2) | 210.43 nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 3A (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 3A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4A (n=4) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MP2 (n=2) | 166.73 nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1B (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MCP1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4:Cohort MB 3B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MCP1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4B (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 3 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort -2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 4 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 5 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort OCE -1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 5 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP1 (n=1) | 339.35 nanogram per millileter (ng/mL) | — |
| MEDI3617 + PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort OCE -1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 2 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4B (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort -2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MCP1 (n=2) | 348.53 nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 5 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MCP1 (n=2) | 336.31 nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort 3 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 3A (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP1 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MP2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 4 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 3 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 1B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MP2 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 1B (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2A (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 2B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort -1 (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort OCE -1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 5 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 2B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort OCE -1 (n=3) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 4A (n=2) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort MB 4A (n=4) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4: Cohort 2 (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 4:Cohort MB 3B (n=1) | NA nanogram per millileter (ng/mL) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Circulating Levels of Angiopoietin 2 (Ang2) | Cycle 5: Cohort MB 3A (n=2) | NA nanogram per millileter (ng/mL) | — |
Secondary
Duration of Response (DOR)
Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.
Time frame: Time from the first dose of investigational product until end of study
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Duration of Response (DOR) | 3.7 months |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Duration of Response (DOR) | NA months |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Duration of Response (DOR) | NA months |
| MEDI3617 + PACLITAXEL TOTAL | Duration of Response (DOR) | NA months |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Duration of Response (DOR) | NA months |
Secondary
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cmax is the maximum observed serum concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose.
Time frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
Population: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP2 (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort OCE 1 (n=2) | 346 microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort TT2A (n=9) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 4 (n=3) | 239 microgram per milliliter (mcg/ml) | Standard Deviation 79.5 |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3B (n=8) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort ovarian cancer expansion (OCE) -1 (n=15) | 336 microgram per milliliter (mcg/ml) | Standard Deviation 62.2 |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -1 (n=2) | 2.44 microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP1 (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 5 (n=4) | 785 microgram per milliliter (mcg/ml) | Standard Deviation 189 |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1B (n=7) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3A (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 2 (n=3) | 50.2 microgram per milliliter (mcg/ml) | Standard Deviation 28.8 |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2B (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4B (n=8) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4A (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 1 (n=6) | 6.63 microgram per milliliter (mcg/ml) | Standard Deviation 3.48 |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP1 (n=7) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2A (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -2 (n=3) | 1.39 microgram per milliliter (mcg/ml) | Standard Deviation 0.254 |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1A (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 SINGLE AGENT TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 3 (n=3) | 82.4 microgram per milliliter (mcg/ml) | Standard Deviation 2.68 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3A (n=3) | 235 microgram per milliliter (mcg/ml) | Standard Deviation 90.5 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort TT2A (n=9) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2B (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3B (n=8) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4A (n=6) | 348 microgram per milliliter (mcg/ml) | Standard Deviation 54.6 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4B (n=8) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 3 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP1 (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 4 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 5 (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -1 (n=2) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort ovarian cancer expansion (OCE) -1 (n=15) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP2 (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort OCE 1 (n=2) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1A (n=4) | 30.4 microgram per milliliter (mcg/ml) | Standard Deviation 26.8 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2A (n=3) | 55.3 microgram per milliliter (mcg/ml) | Standard Deviation 12.6 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP1 (n=7) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1B (n=7) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 1 (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1B (n=7) | 44.5 microgram per milliliter (mcg/ml) | Standard Deviation 39.3 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 3 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP1 (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2B (n=3) | 47.5 microgram per milliliter (mcg/ml) | Standard Deviation 23.3 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1A (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP1 (n=7) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4A (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2A (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4B (n=8) | 275 microgram per milliliter (mcg/ml) | Standard Deviation 86.2 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 5 (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 1 (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP2 (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 4 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3B (n=8) | 116 microgram per milliliter (mcg/ml) | Standard Deviation 35.1 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort ovarian cancer expansion (OCE) -1 (n=15) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -1 (n=2) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort TT2A (n=9) | 320 microgram per milliliter (mcg/ml) | Standard Deviation 170 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3A (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort OCE 1 (n=2) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4B (n=8) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -1 (n=2) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 1 (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 3 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 4 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 5 (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort ovarian cancer expansion (OCE) -1 (n=15) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort OCE 1 (n=2) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1A (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2A (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3A (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4A (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1B (n=7) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2B (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3B (n=8) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort TT2A (n=9) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP1 (n=7) | 114 microgram per milliliter (mcg/ml) | Standard Deviation 22.5 |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP2 (n=6) | 209 microgram per milliliter (mcg/ml) | Standard Deviation 57.4 |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP1 (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 1 (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort TT2A (n=9) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3A (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2A (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1A (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -1 (n=2) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP1 (n=7) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort OCE 1 (n=2) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort ovarian cancer expansion (OCE) -1 (n=15) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 5 (n=4) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort -2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MP2 (n=6) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 4 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 3 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort 2 (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP2 (n=3) | 585 microgram per milliliter (mcg/ml) | Standard Deviation 491 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MCP1 (n=4) | 200 microgram per milliliter (mcg/ml) | Standard Deviation 25.8 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 3B (n=8) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4B (n=8) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 2B (n=3) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 1B (n=7) | NA microgram per milliliter (mcg/ml) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Maximum Observed Serum Concentration (Cmax) of MEDI3617 | Cohort MB 4A (n=6) | NA microgram per milliliter (mcg/ml) | — |
Secondary
Number of Participants With Positive Anti-Drug Antibody (ADA)
The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.
Time frame: Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617
Population: All participants who received treatment with MEDI3617.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Number of Participants With Positive Anti-Drug Antibody (ADA) | 0 participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Number of Participants With Positive Anti-Drug Antibody (ADA) | 0 participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Number of Participants With Positive Anti-Drug Antibody (ADA) | 0 participants |
| MEDI3617 + PACLITAXEL TOTAL | Number of Participants With Positive Anti-Drug Antibody (ADA) | 0 participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Number of Participants With Positive Anti-Drug Antibody (ADA) | 0 participants |
Secondary
Objective Response Rate (ORR)
Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be 0 if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Time from the first dose of investigational product until end of study
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Objective Response Rate (ORR) | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Objective Response Rate (ORR) | 1 Participants |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Objective Response Rate (ORR) | 2 Participants |
| MEDI3617 + PACLITAXEL TOTAL | Objective Response Rate (ORR) | 2 Participants |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Objective Response Rate (ORR) | 0 Participants |
Secondary
Overall Survival (OS)
Overall survival is defined as the time from the start of treatment with MEDI3617 until death. For the participants who were alive at the end of study or lost to follow-up, overall survival was censored on the last date when participants were known to be alive. Overall survival was evaluated using the Kaplan-Meier method.
Time frame: Time from the first dose of investigational product until death due to any cause
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Overall Survival (OS) | 11.4 months |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Overall Survival (OS) | 25.7 months |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Overall Survival (OS) | 7.4 months |
| MEDI3617 + PACLITAXEL TOTAL | Overall Survival (OS) | 14.2 months |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Overall Survival (OS) | NA months |
Secondary
Progression-Free Survival (PFS)
PFS was measured from the start of treatment with MEDI3617 until the documentation of disease progression or death due to any cause, whichever occurred first. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had PFS censored on the first date of treatment with MEDI3617. PFS was evaluated using the Kaplan-Meier method.
Time frame: Time from the first dose of investigational product until end of study
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Progression-Free Survival (PFS) | 1.4 months |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Progression-Free Survival (PFS) | 11.4 months |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Progression-Free Survival (PFS) | 1.7 months |
| MEDI3617 + PACLITAXEL TOTAL | Progression-Free Survival (PFS) | 3.5 months |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Progression-Free Survival (PFS) | NA months |
Secondary
Systemic Clearance (CL) of MEDI3617
Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). Here, n is number of participants analyzed for this endpoint at a specific dose.
Time frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
Population: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP1 (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 4 (n=2) | 465 milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort -2 (n=1) | 2790 milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 1 (n=1) | 2460 milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 2 (n=2) | 423 milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4B (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 5 (n=2) | 355 milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP1 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1A (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4A (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 3B(n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE -1 (n=12) | 352 milliliter per day (mL/day) | Standard Deviation 136 |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP2 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 3 (n=3) | 679 milliliter per day (mL/day) | Standard Deviation 345 |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2A (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2B (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE 1 (n=2) | 603 milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP2 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 SINGLE AGENT TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1B (n=7) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP1 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1A (n=3) | 1060 milliliter per day (mL/day) | Standard Deviation 426 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4A (n=2) | 388 milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2A (n=3) | 614 milliliter per day (mL/day) | Standard Deviation 363 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 2 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP2 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP2 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 3 (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP1 (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 4 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4B (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 5 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 1 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 3B(n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE -1 (n=12) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort -2 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2B (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE 1 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1B (n=7) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2A (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort -2 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 1 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 2 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 3 (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 4 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 5 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE -1 (n=12) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE 1 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1A (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4A (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1B (n=7) | 797 milliliter per day (mL/day) | Standard Deviation 499 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2B (n=3) | 847 milliliter per day (mL/day) | Standard Deviation 237 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 3B(n=2) | 501 milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4B (n=1) | 216 milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP1 (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP2 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP1 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP2 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE 1 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1B (n=7) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE -1 (n=12) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP1 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2B (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 5 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 3B(n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 4 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4B (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 3 (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort -2 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP1 (n=3) | 727 milliliter per day (mL/day) | Standard Deviation 157 |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 2 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP2 (n=1) | 356 milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2A (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1A (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 1 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4A (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP2 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 1 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4A (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1B (n=7) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE -1 (n=12) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2A (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP1 (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 2 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 2B (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 1A (n=3) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 5 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP1 (n=1) | 446 milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MCP2 (n=2) | 424 milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 3B(n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 4 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort OCE 1 (n=2) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort -2 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MP2 (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort MB 4B (n=1) | NA milliliter per day (mL/day) | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Systemic Clearance (CL) of MEDI3617 | Cohort 3 (n=3) | NA milliliter per day (mL/day) | — |
Secondary
Terminal Elimination Half Life (t1/2) of MEDI3617
The t1/2 is the time in days required for the concentration of the drug to reach half of its original value. Here, n is number of participants analyzed for this endpoint at a specific dose.
Time frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
Population: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP1 (n=1) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP1 (n=3) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 4 (n=2) | 7.68 day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort -2 (n=1) | 0.585 day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP2 (n=2) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 2 (n=2) | 5.86 day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4B (n=1) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 5 (n=2) | 7.79 day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1A (n=3) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4A (n=2) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP2 (n=1) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 3B(n=2) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE -1 (n=12) | 10.4 day | Standard Deviation 3.15 |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2A (n=3) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 1 (n=1) | 1.26 day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 3 (n=3) | 5.98 day | Standard Deviation 3.09 |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2B (n=3) | NA day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE 1 (n=2) | 9.03 day | — |
| MEDI3617 SINGLE AGENT TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1B (n=7) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE 1 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1B (n=7) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1A (n=3) | 3.59 day | Standard Deviation 0.983 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4A (n=2) | 12.3 day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2A (n=3) | 9.67 day | Standard Deviation 3.35 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP2 (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 2 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort -2 (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP1 (n=3) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 3 (n=3) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP2 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 4 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4B (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 5 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP1 (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 3B(n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE -1 (n=12) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2B (n=3) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 1 (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2A (n=3) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort -2 (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 1 (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 2 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 3 (n=3) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 4 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 5 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE -1 (n=12) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE 1 (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1A (n=3) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4A (n=2) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1B (n=7) | 3.9 day | Standard Deviation 2.69 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2B (n=3) | 5.12 day | Standard Deviation 0.541 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 3B(n=2) | 8.23 day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4B (n=1) | 10.2 day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP1 (n=3) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP2 (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP1 (n=1) | NA day | — |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP2 (n=2) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP2 (n=2) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1B (n=7) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE -1 (n=12) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP1 (n=1) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2B (n=3) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 5 (n=2) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 3B(n=2) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 4 (n=2) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort -2 (n=1) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4B (n=1) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 3 (n=3) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP1 (n=3) | 6.96 day | Standard Deviation 1.59 |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 2 (n=2) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP2 (n=1) | 9.34 day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 1 (n=1) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2A (n=3) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1A (n=3) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4A (n=2) | NA day | — |
| MEDI3617 + PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE 1 (n=2) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 2 (n=2) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE 1 (n=2) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1B (n=7) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort OCE -1 (n=12) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2A (n=3) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP1 (n=3) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 1A (n=3) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 2B (n=3) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 5 (n=2) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 1 (n=1) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP1 (n=1) | 15.1 day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MCP2 (n=2) | 11.1 day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 3B(n=2) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 4 (n=2) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4A (n=2) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MP2 (n=1) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort -2 (n=1) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort MB 4B (n=1) | NA day | — |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Terminal Elimination Half Life (t1/2) of MEDI3617 | Cohort 3 (n=3) | NA day | — |
Secondary
Time to Progression (TTP)
Time to progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP was evaluated using the Kaplan-Meier method.
Time frame: Time from the first dose of investigational product until end of study
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Time to Progression (TTP) | 1.4 months |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Time to Progression (TTP) | 11.4 months |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Time to Progression (TTP) | 1.8 months |
| MEDI3617 + PACLITAXEL TOTAL | Time to Progression (TTP) | 3.5 months |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Time to Progression (TTP) | NA months |
Secondary
Time to Response (TTR)
Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be 0 if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated using the Kaplan-Meier method.
Time frame: Time from the first dose of investigational product until end of study
Population: Safety population included all participants who received treatment with MEDI3617.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | Time to Response (TTR) | 2.6 months |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | Time to Response (TTR) | 1.2 months |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | Time to Response (TTR) | 2.0 months |
| MEDI3617 + PACLITAXEL TOTAL | Time to Response (TTR) | 1.7 months |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | Time to Response (TTR) | NA months |