Adenocarcinoma. Gastric cancer.
Conditions
Interventions
354 patients were randomized on a 2:1 basis, to IMC-1121B plus BSC (around 236 patients) or to placebo plus BSC (around 118 patients), respectively. Patients in the active-treatment group have receive
drug
biological/vaccine
HP3.073.433.101
Sponsors
ImClone Systems Incorporated
Quintiles Brasil Ltda
PAREXEL International
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma; metastatic disease or locally recurrent; unresectable disease with measurable lymph node metastases; measurable disease and/or evaluable disease. ; 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; disease not amenable to potentially curative resection; patient is over 18 years old; there is no maximum age for enrollment in the study; patient has a life expectancy of 12 or more weeks; patient resolution to Grade = 1 (or to Grade = 2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.02, of all significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia); Eastern Cooperative Oncology Group Performance Status score of 0-1; adequate hepatic function; adequate renal function; urinary protein is = 1+ on dipstick or routine urinalysis; adequate hematologic function; adequate coagulation function. ; if the patient has received prior anthracycline therapy as part of his or her first-line regimen, the patient is able to engage in ordinary physical activity without significant fatigue or dyspnea; patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods); female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization; able to provide informed written consent and is amenable to compliance with protocol schedules and testing.
Exclusion criteria
Exclusion criteria: Brain or leptomeningeal metastases. Experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization; experienced any arterial thromboembolic events within 6 months prior to randomization; 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; ongoing or active psychiatric illness or social situation that would limit compliance with study requirements; uncontrolled or poorly-controlled hypertension; patient has a serious or nonhealing wound, ulcer, or bone fracture. Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to randomization; received any investigational therapy within 1 year prior to randomization; undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization; received prior therapy with an agent that directly inhibits VEGF or VEGFR-2 activity, or any antiangiogenic agent. Receiving chronic antiplatelet therapy; known allergy to any of the treatment components; pregnant or lactating; known to be positive for infection with the human immunodeficiency virus; known alcohol or drug dependency; concurrent active malignancy other than adequately-treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm; patient with previous history of malignancy is eligible, provided that he/she has been free of disease for > 3 years.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints will include the evaluation of the progression-free survival (PFS), including 12-week PFS rate, associated with IMC-1121B versus placebo; the objective response rate (ORR); the duration of response; the quality of life (QoL); the safety profile of IMC-1121B; the pharmacodynamic profile of IMC-1121B and the immunogenicity of IMC-1121B. | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Guatemala, India, Indonesia, Italy, Korea, Democratic People's Republic of, Lebanon, Malaysia, Malta, Mexico, New Zealand, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Province of China, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactMinori;Rodrigo Koshiji;Guimarães
ImClone Systems Incorporated;Quintiles Brasil Ltda
Outcome results
None listed