A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy - ND

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2008-005964-15-IT
• Date of registration: 10/12/2009
• Prospective Registration: Yes
• Primary sponsor: IMCLONE LLC
• Public title: A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy - ND
• Scientific title: A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy - ND
• Date of first enrolment: 08/01/2010
• Target sample size: 615
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005964-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Italy, Malta, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. The patient has histologically- or cytologically-confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma (patients with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ). 2. The patient has metastatic disease or locally recurrent, unresectable disease.  Patients with nonregional lymph node metastases are eligible; lymph node metastases must be measurable as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0.[56]  Patients with locally-recurrent, unresectable disease are eligible.  For patients who have received prior radiation therapy, measurable or evaluable lesions must be outside the radiation field, or (for lesions within the radiation field) there must be documented progression following radiation therapy. For the complete list please refer to the Protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
The patient has documented and/or symptomatic brain or leptomeningeal metastases. 2. The patient has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization. 3. The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization. For the complete list please refer to the Protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Metastatic Gastric Cancer
MedDRA version: 12.1 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction

Intervention(s)

Product Name: Ramucirumab
Product Code: IMC-1121B
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ramucirumab
CAS Number: 947687-13-0
Current Sponsor code: IMC-1121B
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Product Name: Ramucirumab
Product Code: IMC-1121B
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ramucirumab
CAS Number: 947687-13-0
Current Sponsor code: IMC-1121B
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective:  To evaluate the progression-free survival (PFS), including 12-week PFS rate, associated with IMC-1121B versus placebo  To evaluate the objective response rate (ORR)  To evaluate the duration of response  To evaluate the quality of life (QoL)  To evaluate the safety profile of IMC-1121B  To examine the pharmacodynamic profile of IMC-1121B  To assess the immunogenicity of IMC-1121B

Main Objective: To evaluate the overall survival (OS) of patients with metastatic gastric cancer (including adenocarcinomas of the gastroesophageal junction [GEJ]) following disease progression on first-line platinum- or fluoropyrimidine-containing combination chemotherapy who undergo treatment with the MAb IMC-1121B plus BSC versus placebo plus BSC.

Primary end point(s): Overall Survival Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the patient is alive at the end of the follow-up period or is lost to followup, OS data will be censored on the last date the patient is known to be alive. OS will be evaluated by the Kaplan-Meier method, and a 95% confidence interval (CI) will be provided for the median OS. for a complete description please refer to the Protocol.

Secondary ID(s)

IMCL CP12-0715