Phase II Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone Administered Intravenously to Patients With Colorectal Adenocarcinoma Previously Untreated for Metastatic Disease
Overview
- Phase
- Phase 2
- Intervention
- CT-011
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Medivation, Inc.
- Enrollment
- 171
- Locations
- 31
- Primary Endpoint
- The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.
Detailed Description
The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient's age is 18 years or older, both genders.
- •Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
- •ECOG performance status ≤ 1
- •At least 4 weeks from prior major surgery or radiotherapy.
- •Life expectancy \>3 months
- •Hematology: ANC ≥ 1.5X109/L; Platelets \>100x109/L.
- •Adequate Renal function
- •Adequate Hepatic functions
- •Normal Cardiac function
Exclusion Criteria
- •Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
- •Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
- •Patients on concurrent anti cancer therapy other than that allowed in the study.
- •Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
- •Presence of clinically apparent or suspected brain metastasis.
- •Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
- •Serious active infection at the time of pre-study screening.
- •Active or history of autoimmune disorders/conditions.
- •Women who are pregnant or lactating
- •Concurrent active malignancy.
Arms & Interventions
CT-011 in combination with FOLFOX
CT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance. FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
Intervention: CT-011
CT-011 in combination with FOLFOX
CT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance. FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
Intervention: FOLFOX
FOLFOX
FOLFOX (FOLFOX-4 or mFOLFOX6) administered every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
Intervention: FOLFOX
Outcomes
Primary Outcomes
The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone.
Time Frame: 32 months
Secondary Outcomes
- Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.(32 months)
- Anti tumor activity of the antibody.(32 months)
- Objective response rate by RECIST.(32 months)
- Progression-free survival rates.(32 months)
- Response duration.(32 months)
- Overall survival.(32 months)
- Tumor and immunological markers.(32 months)