Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Ramucirumab

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Each treatment cycle is 4 weeks (28 days)

8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle

Ramucirumab (IMC-1121B )

80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.

Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas

A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas

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.

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.

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.

Cmax after a single dose of ramucirumab (IMC-1121B).

The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.

AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).

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).

CL \[the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time\] after a single dose of ramucirumab (IMC-1121B).

Vss \[distribution of ramucirumab (IMC-1121B) in the body at steady state\] after a single dose of ramucirumab (IMC-1121B).

Cmax after multiple doses of ramucirumab (IMC-1121B).

AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).

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).

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).

Vss \[distribution of ramucirumab (IMC-1121B) in in the body at steady state\] is not calculated for multiple doses of ramucirumab (IMC-1121B).

Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in 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.

Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.

Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.

Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.

Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in 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.

Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.

Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.

Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.

Eli Lilly and Company

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.

Ramucirumab + Paclitaxel

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Japan

Region of Enrollment

Cycle 3 and beyond pharmacokinetic sampling was collected per the protocol-defined limited sampling schedule.

Chief Medical Officer

All enrolled participants who complete the first cycle of study drug or discontinued study drug due to a DLT during Cycle 1.

Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1

RAM-Related AEs Any Grade

PAC-Related AEs Any Grade

RAM-Related AEs Any Grade ≥3

PAC-Related AEs Any Grade ≥3

RAM-Related AEs Resulting in Death

PAC-Related AEs Resulting in Death

All enrolled participants who received any quantity of study drug.

Number of Participants With Adverse Events (AEs)

RAM-Related SAEs

PAC-Related SAEs

Number of Participants With Serious Adverse Events (SAEs)

All enrolled participants who received any quantity of study drug and had evaluable Cmax values.

Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1

All enrolled participants who received at least 1 dose of study drug and were analyzed for anti-ramucirumab (IMC-1121B) antibodies.

Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)

All enrolled participants who received any quantity of study drug and had evaluable AUC0-∞ values.

Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1

All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.

Ramucirumab Half-Life (t1/2) for Cycle 1

All enrolled participants who received any quantity of study drug and had evaluable CL values.

Ramucirumab Clearance (CL) or Cycle 1

All enrolled participants who received any quantity of study drug and had evaluable Vss values.

Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1

Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2

All enrolled participants who received any quantity of study drug and had evaluable AUC 0-τ values.

Spots Global Cancer Trial Database for Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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