Adenocarcinoma
Conditions
Keywords
Adenocarcinoma, Gastroesophageal Junction
Brief summary
Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.
Interventions
BIOLOGICALRamucirumab (IMC-1121B )
8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
DRUGPaclitaxel
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma * Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard therapy * Has resolution of all clinically significant toxic effects of prior therapy, surgery, treatment with an investigational agent or device, treatment monoclonal antibody or small molecule, and radiotherapy or chemotherapy. * Has adequate organ function * Eligible participants of reproductive potential (both sexes) agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication
Exclusion criteria
* Has undergone major surgery within 28 days prior to the study, or subcutaneous venous access device placement within 7 days prior to the study registration date * Has elective or planned surgery to be conducted during the trial * Has had treatment with an investigational agent or device, an antineoplastic small molecule, or antineoplastic radiotherapy or chemotherapy * Was previously treated with a chemotherapy regimen containing nitrosoureas or mitomycin C * Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to the study registration date * Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism prior to the study registration date * Has experienced any arterial thrombotic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the study date * Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. (Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters International Normalized Ratio (INR) ≤ 1.5, prothrombin time (PT) and partial thromboplastin time (PTT) or - Is receiving chronic therapy with nonsteroidal anti-inflammatory agents \[Aspirin use at doses up to 325 milligrams/day (mg/day) is permitted\] * Has significant bleeding disorders, vasculitis, history of postoperative bleeding complications, hemoptysis or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to the study date * Has a history of GI perforation and/or fistulae within 6 months prior to the study date * Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia * Has uncontrolled arterial hypertension despite standard medical management. * Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to the study date * Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea * Has a serious illness or medical condition(s) * Is pregnant or lactating * Has received treatment with another investigational drug or participation in another interventional clinical trial within 28 days prior to the study date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1 | Cycle 1 of 28-day cycle | DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia \>5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc\>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation. SD tox=delay \>1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay \>2 weeks between Cy 1 and Cy 2 due to persistent tox. |
| Number of Participants With Adverse Events (AEs) | Up to 47 weeks post baseline | The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab \[RAM (IMC-1121B)\] or paclitaxel (PAC). A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module. |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 47 weeks post baseline | The number of participants who experienced SAEs that were considered to be related to ramucirumab \[RAM (IMC-1121B)\] or paclitaxel (PAC). A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ramucirumab Half-Life (t1/2) for Cycle 1 | Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B). |
| Ramucirumab Clearance (CL) or Cycle 1 | Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | CL \[the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time\] after a single dose of ramucirumab (IMC-1121B). |
| Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1 | Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | Vss \[distribution of ramucirumab (IMC-1121B) in the body at steady state\] after a single dose of ramucirumab (IMC-1121B). |
| Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2 | Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | Cmax after multiple doses of ramucirumab (IMC-1121B). |
| Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2 | Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B). |
| Ramucirumab Half-Life (t1/2) for Cycle 2 | Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | Terminal t1/2 \[the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%\] after multiple doses of ramucirumab(IMC-1121B). |
| Ramucirumab Clearance (CL) for Cycle 2 | Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | CL \[the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time\] at steady state after multiple doses of ramucirumab (IMC-1121B). |
| Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2 | Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | Vss \[distribution of ramucirumab (IMC-1121B) in in the body at steady state\] is not calculated for multiple doses of ramucirumab (IMC-1121B). |
| Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3 | Cycle 3: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3. |
| Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1 | Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | Cmax after a single dose of ramucirumab (IMC-1121B). |
| Ramucirumab Half-Life (t 1/2) for Cycle 3 | Cycle 3: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3. |
| Ramucirumab Clearance (CL) for Cycle 3 | Cycle 3: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3. |
| Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3 | Cycle 3: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3. |
| Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4 | Cycle 4: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4. |
| Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4 | Cycle 4: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4. |
| Ramucirumab Half-Life (t 1/2) for Cycle 4 | Cycle 4: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4. |
| Ramucirumab Clearance (CL) for Cycle 4 | Cycle 4: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4. |
| Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4 | Cycle 4: Pre-infusion, Day 1 of 28-day cycle | Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4. |
| Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3 | Cycle 3: Pre-infusion, Day 1 of 28-day cycle | Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3. |
| Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity) | Cycle 1 through Cycle 5 (28-day cycles) | The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies. |
| Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1 | Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle | AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B). |
Countries
Japan
Participant flow
Pre-assignment details
Participants were considered completed if they either completed Cycle 1 of study drug or discontinued study drug due to a dose limiting toxicity (DLT) during Cycle 1.
Participants by arm
| Arm | Count |
|---|---|
| Ramucirumab + Paclitaxel Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.
Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Ramucirumab + Paclitaxel |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 15.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 4 / 6 |
Outcome results
Primary
Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia \>5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc\>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation. SD tox=delay \>1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay \>2 weeks between Cy 1 and Cy 2 due to persistent tox.
Time frame: Cycle 1 of 28-day cycle
Population: All enrolled participants who complete the first cycle of study drug or discontinued study drug due to a DLT during Cycle 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ramucirumab + Paclitaxel | Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1 | 0 participants |
Primary
Number of Participants With Adverse Events (AEs)
The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab \[RAM (IMC-1121B)\] or paclitaxel (PAC). A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Up to 47 weeks post baseline
Population: All enrolled participants who received any quantity of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ramucirumab + Paclitaxel | Number of Participants With Adverse Events (AEs) | RAM-Related AEs Any Grade | 6 participants |
| Ramucirumab + Paclitaxel | Number of Participants With Adverse Events (AEs) | PAC-Related AEs Any Grade | 6 participants |
| Ramucirumab + Paclitaxel | Number of Participants With Adverse Events (AEs) | RAM-Related AEs Any Grade ≥3 | 2 participants |
| Ramucirumab + Paclitaxel | Number of Participants With Adverse Events (AEs) | PAC-Related AEs Any Grade ≥3 | 4 participants |
| Ramucirumab + Paclitaxel | Number of Participants With Adverse Events (AEs) | RAM-Related AEs Resulting in Death | 0 participants |
| Ramucirumab + Paclitaxel | Number of Participants With Adverse Events (AEs) | PAC-Related AEs Resulting in Death | 0 participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
The number of participants who experienced SAEs that were considered to be related to ramucirumab \[RAM (IMC-1121B)\] or paclitaxel (PAC). A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Up to 47 weeks post baseline
Population: All enrolled participants who received any quantity of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ramucirumab + Paclitaxel | Number of Participants With Serious Adverse Events (SAEs) | RAM-Related SAEs | 2 participants |
| Ramucirumab + Paclitaxel | Number of Participants With Serious Adverse Events (SAEs) | PAC-Related SAEs | 2 participants |
Secondary
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1
AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).
Time frame: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable AUC0-∞ values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1 | 34100 micrograms*hour/milliliter (µg*h/mL) |
Secondary
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2
AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable AUC 0-τ values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2 | 41900 micrograms*hour/milliliter (µg*h/mL) | Standard Deviation 951 |
Secondary
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3
Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4
Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Clearance (CL) for Cycle 2
CL \[the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time\] at steady state after multiple doses of ramucirumab (IMC-1121B).
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable CL values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Clearance (CL) for Cycle 2 | 0.0136 liters/hour (L/h) | Standard Deviation 0.000342 |
Secondary
Ramucirumab Clearance (CL) for Cycle 3
Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Clearance (CL) for Cycle 4
Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Clearance (CL) or Cycle 1
CL \[the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time\] after a single dose of ramucirumab (IMC-1121B).
Time frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable CL values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Clearance (CL) or Cycle 1 | 0.0166 liters/hour (L/h) |
Secondary
Ramucirumab Half-Life (t1/2) for Cycle 1
Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).
Time frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Half-Life (t1/2) for Cycle 1 | 190 hours (h) |
Secondary
Ramucirumab Half-Life (t1/2) for Cycle 2
Terminal t1/2 \[the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%\] after multiple doses of ramucirumab(IMC-1121B).
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Half-Life (t1/2) for Cycle 2 | 218 hours (h) |
Secondary
Ramucirumab Half-Life (t 1/2) for Cycle 3
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Half-Life (t 1/2) for Cycle 4
Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Cmax after a single dose of ramucirumab (IMC-1121B).
Time frame: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable Cmax values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1 | 176 micrograms/milliliter (µg/mL) | Standard Deviation 46.6 |
Secondary
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2
Cmax after multiple doses of ramucirumab (IMC-1121B).
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable Cmax values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2 | 284 micrograms/milliliter (µg/mL) | Standard Deviation 39.7 |
Secondary
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1
Vss \[distribution of ramucirumab (IMC-1121B) in the body at steady state\] after a single dose of ramucirumab (IMC-1121B).
Time frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: All enrolled participants who received any quantity of study drug and had evaluable Vss values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ramucirumab + Paclitaxel | Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1 | 3.27 liters (L) |
Secondary
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2
Vss \[distribution of ramucirumab (IMC-1121B) in in the body at steady state\] is not calculated for multiple doses of ramucirumab (IMC-1121B).
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3
Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4
Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Population: Zero participants were analyzed.
Secondary
Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.
Time frame: Cycle 1 through Cycle 5 (28-day cycles)
Population: All enrolled participants who received at least 1 dose of study drug and were analyzed for anti-ramucirumab (IMC-1121B) antibodies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ramucirumab + Paclitaxel | Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity) | 0 percentage of participants |