NCT00813605
Completed
Phase 2
A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma
ConditionsMetastatic Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- NantCell, Inc.
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
- •Mutant-type KRAS tumor at screening
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
- •Adequate hematology, renal, hepatic, and coagulation function
Exclusion Criteria
- •History or known presence of central nervous system metastases
- •History of other malignancy
- •Prior irinotecan-based chemotherapy for advanced/metastatic disease
- •Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
- •Uncontrolled cardiovascular disease
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: Length of Study
Secondary Outcomes
- Significant laboratory abnormalities(Length of Study)
- Incidence of antibody formation(Length of Study)
- Overall Survival, Objective Response, Duration of Response, Time to Response(Length of Study)
- Incidence of adverse events(Length of Study)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic MigraineChronic MigraineChronic Migraine, HeadacheChronic Migraine Without AuraAura MigraineNCT05679908Tonix Pharmaceuticals, Inc.88
Completed
Phase 2
A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.AdrenoleukodystrophyNCT03231878Minoryx Therapeutics, S.L.105
Terminated
Phase 2
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic DermatitisAtopic DermatitisNCT05048056Akesobio Australia Pty Ltd79
Recruiting
Phase 2
Efficacy and Safety of HB0034 in Patients With Generalized Pustular Psoriasis (GPP)Generalized Pustular Psoriasis (GPP)NCT06231381Shanghai Huaota Biopharmaceutical Co., Ltd.33
Completed
Phase 2
Study of CA-008 (Vocacapsaicin) in Total Knee ArthroplastyPostsurgical PainNCT03731364Concentric Analgesics55