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| Sponsor: | CureTech Ltd |
|---|---|
| Information provided by (Responsible Party): | CureTech Ltd |
| ClinicalTrials.gov Identifier: | NCT00890305 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Drug: CT-011 Drug: FOLFOX |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 168 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
CT-011 in combination with FOLFOX chemotherapy
|
Drug: CT-011
A total of up to 9 doses of CT-011 (3 mg/kg) will be given.
Drug: FOLFOX
24 cycles (every two weeks) of FOLFOX chemotherapy regimen. Drugs: Folinic acid, Fluorouracil, and Oxaliplatin |
|
Active Comparator: 2
FOLFOX chemotherapy
|
Drug: FOLFOX
24 cycles (every two weeks) of FOLFOX chemotherapy regimen. Drugs: Folinic acid, Fluorouracil, and Oxaliplatin |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 31 Study Locations
More Information
| Responsible Party: | CureTech Ltd |
| ClinicalTrials.gov Identifier: | NCT00890305 History of Changes |
| Other Study ID Numbers: | CT-2008-01, 2009-014593-18 |
| Study First Received: | April 28, 2009 |
| Last Updated: | August 30, 2011 |
| Health Authority: | United States: Food and Drug Administration; India: Drugs Controller General of India; Romania: National Medicines Agency; Bulgaria: Bulgarian Drug Agency |
|
Metastatic colorectal cancer FOLFOX chemotherapy |
|
Adenocarcinoma Colorectal Neoplasms Neoplasm Metastasis Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |