Advanced Solid Tumors, Carcinoid, Colorectal Cancer, Locally Advanced, Lymphoma, Metastatic Cancer, Non-Small Cell Lung Cancer, Sarcoma, Solid Tumors
Conditions
Keywords
AMG 655, AMG 479, Apoptosis, Monoclonal Antibody, Tumor Necrosis Factor, Insulin-like Growth Factor, Bevacizumab, Modified FOLFOX6, mFOLFOX6, FOLFOX, Lymphoma, Trail Receptor, ganitumab, conatumumab
Brief summary
The purpose of this protocol is to allow continued treatment with conatumumab and/or ganitumab, with or without chemotherapy, to participants who completed a separate Amgen-sponsored conatumumab or ganitumab study without disease progression whose previous studies were closed.
Interventions
DRUGModified FOLFOX6
The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days.
BIOLOGICALConatumumab
Administered by intravenous infusion Q2W or Q3W.
BIOLOGICALGanitumab
Administered by intravenous infusion Q3W or Q4W.
BIOLOGICALBevacizumab
Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* To be enrolled in this study, subjects must be currently enrolled in a prior Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or AMG 479 alone. Subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol
Exclusion criteria
* Discontinued from a conatumumab study due to an adverse event considered by the investigator to be related to conatumumab treatment, including intolerance to conatumumab * Subjects determined to have disease progression during their participation in the parent Amgen study * Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last dose of protocol-specified therapy administration * Subject is pregnant or breast feeding, or planning to become pregnant within 6 months after the last dose of protocol-specified therapy administration * Male subject with a pregnant partner who is not willing to use a condom during treatment and for an additional 6 months after the last dose of protocol-specified therapy administration * Subject has previously entered this study * Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge * Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. | An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. |
| Number of Participants With Serious Adverse Events | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. | A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. | Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. |
| Maximum Change From Baseline in Blood Pressure | Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. | Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits. |
| Number of Participants With Disease Progression or Death Due to Disease Progression | From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. | — |
| Best Overall Response | Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. | Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease. |
| Minimum Change From Baseline in Blood Pressure | Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. | Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits. |
Countries
Poland, Spain, United States
Participant flow
Recruitment details
This study enrolled participants with different types of solid tumors who had completed one of the following Amgen-sponsored conatumumab or ganitumab studies: 20050118 (NCT00562380) 20050171 20060295 (NCT00534027) 20060340 (NCT00791011) 20060464 (NCT00625651) 20070411 (NCT00819169). Participants who had not progressed in the parent study were eligible to participate in this trial. The study was conducted at 12 centers in the United States, Spain, and Poland.
Pre-assignment details
This was an extension study that permitted participants to continue treatment with conatumumab, with or without co-therapy (modified FOLFOX6 chemotherapy with or without bevacizumab, or ganitumab), or with ganitumab alone, administered at the same dose level and schedule that participants received at the conclusion of the parent study. Participants remained on treatment until disease progression, intolerability, or withdrawal of consent. Results are reported by parent study and treatment.
Participants by arm
| Arm | Count |
|---|---|
| 20050118: Ganitumab 20 mg/kg Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion. | 2 |
| 20050171: Conatumumab 0.45 mg/kg Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion. | 1 |
| 20060295: Conatumumab 3 mg/kg Conatumumab 3 mg/kg every 3 weeks by intravenous infusion. | 1 |
| 20060340: Conatumumab 5 mg/kg Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion. | 1 |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks. | 2 |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks. | 3 |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion. | 2 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Administrative Decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Disease Progression | 1 | 1 | 1 | 0 | 1 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 20050171: Conatumumab 0.45 mg/kg | 20060295: Conatumumab 3 mg/kg | 20060340: Conatumumab 5 mg/kg | 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | 20050118: Ganitumab 20 mg/kg | 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 57.0 years | 44.0 years | 46.0 years | 66.5 years STANDARD_DEVIATION 7.8 | 60.0 years STANDARD_DEVIATION 14.1 | 56.3 years STANDARD_DEVIATION 8.7 | 68.0 years STANDARD_DEVIATION 15.6 | 58.8 years STANDARD_DEVIATION 11.1 |
| Age, Customized 18 - 64 years | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 8 Participants |
| Age, Customized 65 - 74 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Age, Customized 75 - 84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized ≥ 85 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 7 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 | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 1 | 1 / 2 | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 2 / 2 | 1 / 1 | 1 / 1 | 1 / 1 | 2 / 2 | 3 / 3 | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 | 0 / 1 | 1 / 1 | 0 / 1 | 1 / 2 | 3 / 3 | 2 / 2 |
Outcome results
Primary
Number of Participants With Adverse Events
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.
Time frame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Population: Participants who received at least one dose of conatumumab or ganitumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 20050118: Ganitumab 20 mg/kg | Number of Participants With Adverse Events | 2 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Number of Participants With Adverse Events | 1 Participants |
| 20060295: Conatumumab 3 mg/kg | Number of Participants With Adverse Events | 1 Participants |
| 20060340: Conatumumab 5 mg/kg | Number of Participants With Adverse Events | 1 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Number of Participants With Adverse Events | 2 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Number of Participants With Adverse Events | 3 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Number of Participants With Adverse Events | 2 Participants |
Primary
Number of Participants With Serious Adverse Events
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event.
Time frame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Population: Participants who received at least one dose of conatumumab or ganitumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 20050118: Ganitumab 20 mg/kg | Number of Participants With Serious Adverse Events | 1 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Number of Participants With Serious Adverse Events | 0 Participants |
| 20060295: Conatumumab 3 mg/kg | Number of Participants With Serious Adverse Events | 1 Participants |
| 20060340: Conatumumab 5 mg/kg | Number of Participants With Serious Adverse Events | 0 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Number of Participants With Serious Adverse Events | 1 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Number of Participants With Serious Adverse Events | 3 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Number of Participants With Serious Adverse Events | 2 Participants |
Secondary
Best Overall Response
Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease.
Time frame: Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Population: Participants who received at least one dose of conatumumab or ganitumab.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | Best Overall Response | Complete response | 0 Participants |
| 20050118: Ganitumab 20 mg/kg | Best Overall Response | Partial response | 0 Participants |
| 20050118: Ganitumab 20 mg/kg | Best Overall Response | Stable disease | 2 Participants |
| 20050118: Ganitumab 20 mg/kg | Best Overall Response | Progressive disease | 0 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Best Overall Response | Progressive disease | 0 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Best Overall Response | Stable disease | 0 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Best Overall Response | Complete response | 1 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Best Overall Response | Partial response | 0 Participants |
| 20060295: Conatumumab 3 mg/kg | Best Overall Response | Stable disease | 1 Participants |
| 20060295: Conatumumab 3 mg/kg | Best Overall Response | Partial response | 0 Participants |
| 20060295: Conatumumab 3 mg/kg | Best Overall Response | Complete response | 0 Participants |
| 20060295: Conatumumab 3 mg/kg | Best Overall Response | Progressive disease | 0 Participants |
| 20060340: Conatumumab 5 mg/kg | Best Overall Response | Complete response | 1 Participants |
| 20060340: Conatumumab 5 mg/kg | Best Overall Response | Partial response | 0 Participants |
| 20060340: Conatumumab 5 mg/kg | Best Overall Response | Stable disease | 0 Participants |
| 20060340: Conatumumab 5 mg/kg | Best Overall Response | Progressive disease | 0 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Best Overall Response | Complete response | 1 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Best Overall Response | Progressive disease | 0 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Best Overall Response | Partial response | 1 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Best Overall Response | Stable disease | 0 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Best Overall Response | Partial response | 1 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Best Overall Response | Complete response | 0 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Best Overall Response | Stable disease | 2 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Best Overall Response | Progressive disease | 0 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Best Overall Response | Stable disease | 1 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Best Overall Response | Complete response | 0 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Best Overall Response | Partial response | 1 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Best Overall Response | Progressive disease | 0 Participants |
Secondary
Maximum Change From Baseline in Blood Pressure
Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.
Time frame: Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Population: Participants who received at least one dose of conatumumab or ganitumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | Maximum Change From Baseline in Blood Pressure | Systolic blood pressure | 5.5 mmHg | Standard Deviation 9.2 |
| 20050118: Ganitumab 20 mg/kg | Maximum Change From Baseline in Blood Pressure | Diastolic blood pressure | 7.5 mmHg | Standard Deviation 9.2 |
| 20050171: Conatumumab 0.45 mg/kg | Maximum Change From Baseline in Blood Pressure | Systolic blood pressure | 7.0 mmHg | — |
| 20050171: Conatumumab 0.45 mg/kg | Maximum Change From Baseline in Blood Pressure | Diastolic blood pressure | 1.0 mmHg | — |
| 20060295: Conatumumab 3 mg/kg | Maximum Change From Baseline in Blood Pressure | Systolic blood pressure | 54.0 mmHg | — |
| 20060295: Conatumumab 3 mg/kg | Maximum Change From Baseline in Blood Pressure | Diastolic blood pressure | 10.0 mmHg | — |
| 20060340: Conatumumab 5 mg/kg | Maximum Change From Baseline in Blood Pressure | Systolic blood pressure | 37.0 mmHg | — |
| 20060340: Conatumumab 5 mg/kg | Maximum Change From Baseline in Blood Pressure | Diastolic blood pressure | 13.0 mmHg | — |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Maximum Change From Baseline in Blood Pressure | Systolic blood pressure | 42.0 mmHg | Standard Deviation 0 |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Maximum Change From Baseline in Blood Pressure | Diastolic blood pressure | 27.5 mmHg | Standard Deviation 9.2 |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Maximum Change From Baseline in Blood Pressure | Systolic blood pressure | 26.0 mmHg | Standard Deviation 17.3 |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Maximum Change From Baseline in Blood Pressure | Diastolic blood pressure | 14.7 mmHg | Standard Deviation 6.4 |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Maximum Change From Baseline in Blood Pressure | Systolic blood pressure | 32.5 mmHg | Standard Deviation 31.8 |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Maximum Change From Baseline in Blood Pressure | Diastolic blood pressure | 23.5 mmHg | Standard Deviation 6.4 |
Secondary
Minimum Change From Baseline in Blood Pressure
Minimum change from baseline is defined for each participant as the minimum change from baseline value observed across all visits.
Time frame: Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Population: Participants who received at least one dose of conatumumab or ganitumab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | Minimum Change From Baseline in Blood Pressure | Diastolic blood pressure | -19.5 mmHg | Standard Deviation 9.2 |
| 20050118: Ganitumab 20 mg/kg | Minimum Change From Baseline in Blood Pressure | Systolic blood pressure | -28.5 mmHg | Standard Deviation 17.7 |
| 20050171: Conatumumab 0.45 mg/kg | Minimum Change From Baseline in Blood Pressure | Systolic blood pressure | -45.0 mmHg | — |
| 20050171: Conatumumab 0.45 mg/kg | Minimum Change From Baseline in Blood Pressure | Diastolic blood pressure | -27.0 mmHg | — |
| 20060295: Conatumumab 3 mg/kg | Minimum Change From Baseline in Blood Pressure | Systolic blood pressure | -20.0 mmHg | — |
| 20060295: Conatumumab 3 mg/kg | Minimum Change From Baseline in Blood Pressure | Diastolic blood pressure | -20.0 mmHg | — |
| 20060340: Conatumumab 5 mg/kg | Minimum Change From Baseline in Blood Pressure | Systolic blood pressure | -21.0 mmHg | — |
| 20060340: Conatumumab 5 mg/kg | Minimum Change From Baseline in Blood Pressure | Diastolic blood pressure | -25.0 mmHg | — |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Minimum Change From Baseline in Blood Pressure | Systolic blood pressure | -22.5 mmHg | Standard Deviation 16.3 |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Minimum Change From Baseline in Blood Pressure | Diastolic blood pressure | -8.5 mmHg | Standard Deviation 7.8 |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Minimum Change From Baseline in Blood Pressure | Systolic blood pressure | -29.0 mmHg | Standard Deviation 10.8 |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Minimum Change From Baseline in Blood Pressure | Diastolic blood pressure | -14.3 mmHg | Standard Deviation 5.5 |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Minimum Change From Baseline in Blood Pressure | Diastolic blood pressure | -10.0 mmHg | Standard Deviation 4.2 |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Minimum Change From Baseline in Blood Pressure | Systolic blood pressure | -12.0 mmHg | — |
Secondary
Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities
Laboratory toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Population: Participants who received at least one dose of conatumumab or ganitumab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 20050118: Ganitumab 20 mg/kg | Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | 0 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | 0 Participants |
| 20060295: Conatumumab 3 mg/kg | Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | 1 Participants |
| 20060340: Conatumumab 5 mg/kg | Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | 0 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | 2 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | 2 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Number of Participants With CTCAE Grade 3 or Higher Clinical Laboratory Toxicities | 1 Participants |
Secondary
Number of Participants With Disease Progression or Death Due to Disease Progression
Time frame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
Population: Participants who received at least one dose of conatumumab or ganitumab.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Disease progression | 1 Participants |
| 20050118: Ganitumab 20 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Death due to disease progression | 0 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Disease progression | 1 Participants |
| 20050171: Conatumumab 0.45 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Death due to disease progression | 0 Participants |
| 20060295: Conatumumab 3 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Disease progression | 1 Participants |
| 20060295: Conatumumab 3 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Death due to disease progression | 0 Participants |
| 20060340: Conatumumab 5 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Disease progression | 0 Participants |
| 20060340: Conatumumab 5 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Death due to disease progression | 0 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Number of Participants With Disease Progression or Death Due to Disease Progression | Disease progression | 2 Participants |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | Number of Participants With Disease Progression or Death Due to Disease Progression | Death due to disease progression | 1 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Number of Participants With Disease Progression or Death Due to Disease Progression | Disease progression | 2 Participants |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | Number of Participants With Disease Progression or Death Due to Disease Progression | Death due to disease progression | 0 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Disease progression | 2 Participants |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | Number of Participants With Disease Progression or Death Due to Disease Progression | Death due to disease progression | 0 Participants |