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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014593-18 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-011 in combination with FOLFOX | Experimental | 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. |
|
| FOLFOX | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-011 | Drug |
| ||
| FOLFOX |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard B Saltz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cancer Center of Huntsville, PC | Huntsville | Alabama | 35801 | United States | ||
| University of South Florida |
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FOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days. mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours). |
|
| 32 months |
| Progression-free survival rates. | 32 months |
| Response duration. | 32 months |
| Overall survival. | 32 months |
| Tumor and immunological markers. | 32 months |
| Tampa |
| Florida |
| 33606 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10017 | United States |
| Signal Point Clinical Research Center | Middletown | Ohio | 45042 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| MHAT "Dr. Tota Venkova" | Gabrovo | Bulgaria |
| InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD | Rousse | Bulgaria |
| InterDistrict Dispensary in Oncology Diseases with Stationary | Shumen | Bulgaria |
| Multiprofile Hospital for Active Treatment "Tsaritza Joanna" | Sofia | Bulgaria |
| Specialized Hospital for Active Treatment for Oncology | Sofia | Bulgaria |
| InterDistrict Dispensary of Oncology Diseases with Stationary | Varna | Bulgaria |
| Multiprofile Hospital for Active Treatment "Sv. Marina", EAD, | Varna | Bulgaria |
| Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences | Sheikhpura, Patna | Bihar | 800 014 | India |
| Cancer Clinic | Nagpur | Maharashtra | 440012 | India |
| Curie Manavata Cancer Centre, Opp. | Nashik | Maharashtra | 422004 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashtra | 411004 | India |
| G. Kuppuswamy Naidu Memorial Hospital | Pappanaickenpalayam, Coimbatore | Tamil Nadu | 641037 | India |
| Hospital Almanzor Aguinaga Asenjo - Chiclayo | Chiclayo | Peru |
| Clinica Ricardo Palma | Lima | Peru |
| Hospital Regional nivel III Cayetano Heredia Essalud Piura | Piura | Peru |
| Ponce School of Medicine/CAIMED Center | Ponce | 00716 | Puerto Rico |
| Fundacion de Investigacion de Diego | Santurce | 00909 | Puerto Rico |
| "Prof. Dr. Ion Chiricuţă" Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Clinical Emergency Hospital - Oncology Department | Constanța | 900591 | Romania |
| Oncolab SRL, No. 1 | Craiova | 200535 | Romania |
| Center of Medical Oncology | Iași | Romania |
| Clinical Hospital Pelican Oradea | Oradea | 410469 | Romania |
| No. 1 City Hospital | Ploieşti | Romania |
| "Sf. Ioan cel Nou" Clinical Emergency County Hospital | Suceava | Romania |
| Clinic of Oncology - Radiotherapy | Tg. Mures | 540141 | Romania |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C585832 | pidilizumab |
| C410216 | Folfox protocol |
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