A clinical trial to study the effects of IMC-1121B and best supportive care (BSC) versus Placebo and BSC in patients with metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first line care.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2010/091/001245
• Date of registration: 13-10-2010
• Prospective Registration: Yes
• Primary sponsor: ImClone LLC
• Public title: A clinical trial to study the effects of IMC-1121B and best supportive care (BSC) versus Placebo and BSC in patients with metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first line care.
• Scientific title: A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatmentof Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaFollowing Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy
• Date of first enrolment: 20-12-2010
• Target sample size: 348
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2042
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Croatia, Czech Republic, Democratic People's Republic of Korea, Egypt, Guatemala, India, Indonesia, Italy, Lebanon, Malta, New Zealand, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States of America

Contacts

• Name: Suneela Thatte

• Name: Dr Sangha Mitra Patnaik

Key inclusion & exclusion criteria

Inclusion criteria: Each patient must meet the following criteria to be enrolled in this study.



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



• 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.



3. The patient has measurable disease and/or evaluable disease. Measurable disease is defined as at least one unidimensionally-measurable target lesion (>= 20 mm with conventional techniques or >= 10 mm by spiral CT), as defined by RECIST Version 1.0. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by RECIST.



4. The patient has experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy.



• Acceptable first-line regimens for this study are combination chemotherapy regimens that include platinum or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-FU, capecitabine, or S-1).



• Elevations in carcinoembryonic antigen or other tumor markers without radiographic evidence of progression do not constitute satisfactory evidence of progression on first-line therapy.



• Patients who are intolerant to first-line chemotherapy regimens are eligible provided there is disease progression within 4 months after the last dose of firstline therapy.



• Patients who have had one or more component(s) of first-line chemotherapy discontinued because of toxicity, but continued to receive the other component(s) of first-line therapy (eg, a FOLFOX regimen in which the oxaliplatin was stopped and the 5-FU/leucovorin was continued), are eligible following disease progression.



• Prior adjuvant therapy is permitted, and patients with disease progression during adjuvant chemotherapy are eligible, provided that disease progression occurs within 6 months after the completion of adjuvant therapy. Patients who experience disease progression more than 6 months after the last dose of adjuvant therapy should receive first-line therapy for metastatic disease, with subsequent progression on first-line therapy a requirement for eligibility.



5. The patientâ??s disease is not amenable to potentially curative resection.



6. The patient is >= 18 years of age.



7. The patient has a life expectancy of >= 12 weeks.



8. The patient has resolution to Grade <= 1 (or to Grade <= 2 i
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study.



1. 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.



4. The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.



5. The patient has ongoing or active psychiatric illness or social situation that would limit compliance with study requirements.



6. The patient has uncontrolled or poorly-controlled hypertension despite standard medical management.



7. The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization.



8. The patient has received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to randomization.



9. The patient has received any investigational therapy within 30 days prior to randomization.



10. The patient has undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization.



11. The patient has received prior therapy with an agent that directly inhibits VEGF or VEGFR-2 activity (including bevacizumab), or any antiangiogenic agent.



12. The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.



13. The patient has elective or planned major surgery to be performed during the course of the clinical trial.



14. The patient has a known allergy to any of the treatment components.



15. The patient is pregnant or lactating.



16. The patient is known to be positive for infection with the human immunodeficiency virus.



17. The patient has known alcohol or drug dependency.



18. The patient has a concurrent active malignancy other than adequately-treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that he/she has been free of disease for > 3 years.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Metastatic gastric cancer

Intervention(s)

Intervention1: IMC-1121B of 5 mg/mL or 10 mg/mL: administered as an intravenous infusion at 8 mg/kg every 2 weeks in the absence of disease progression, toxicity requiring cessation, withdrawn consent, or other withdrawal criteria.
Control Intervention1: Placebo: of 5 mg/mL or 10 mg/mL: administered as an intravenous infusion at 8 mg/kg every 2 weeks in the absence of disease progression, toxicity requiring cessation, withdrawn consent, or other withdrawal criteria.

Primary Outcome(s)

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.Timepoint: The time point of disease progression is evaluated at the point in time when clinically recorded and overall survival at the time of death.

Secondary Outcome(s)

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
Timepoint:

Secondary ID(s)

2008-005964-15

CP12-0715

Source(s) of Monetary Support

ImClone LLC, 33 ImClone Drive, Branchburg, NJ 08876, USA

Secondary Sponsor(s)

PAREXEL International Clinical Research Private Limited

Ethics review

Status: Approved
Approval date: 18/01/2010
Contact:

Institutional Ethics Committee - B.P. Poddar Hospital & Medical Research Ltd

Status: Approved
Approval date: 02/02/2010
Contact:

Institute Ethics Committee - Global Hospitals, Hyderabad

Status: Approved
Approval date: 05/02/2010
Contact:

Ethics Committee - Poona Medical Research Foundation

Status: Approved
Approval date: 08/02/2010
Contact:

CRRT - Kumaran Hospital Ethics Committee

Status: Approved
Approval date: 10/02/2010
Contact:

Institutional Ethics Committee - Apollo Hospitals, Chennai

Status: Approved
Approval date: 20/02/2010
Contact:

Ethics Committee - Apollo Hospital, Hyderabad

Status: Approved
Approval date: 22/02/2010
Contact:

Institutional Ethics Committee - Apollo Gleneagles Hospital, Kolkatta

Status: Approved
Approval date: 03/08/2010
Contact:

Clinical research Ethics Committee - PD Hinduja National Hospital and Medical Research Centre

Status: Approved
Approval date: 18/08/2010
Contact:

Institutional Ethics Committee - CNCI, Kolkata

Status: Approved
Approval date: 25/10/2010
Contact:

Institute Ethics Committee - Indira Gandhi Institute of Medical Sciences

Status: Approved
Approval date: 01/03/2011
Contact:

Medical Ethics Committee - KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY