Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone

Completed · Phase 2

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00890305

Run by

Medivation, Inc.

People needed

171

Starts

2009-05-01

Expected to finish

2013-03-01

Last updated by the study team

2015-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
• Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
• Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
• Patients with history of life threatening allergic reactions to food or drugs
• Patients with symptomatic peripheral neuropathy> Grade 1.
• Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.

Where it is running

• The Cancer Center of Huntsville, PC — Huntsville, Alabama, United States
• University of South Florida — Tampa, Florida, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Signal Point Clinical Research Center — Middletown, Ohio, United States
• Joe Arrington Cancer Research and Treatment Center — Lubbock, Texas, 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, India
• Cancer Clinic — Nagpur, Maharashtra, India
• Curie Manavata Cancer Centre, Opp. — Nashik, Maharashtra, India
• Ruby Hall Clinic — Pune, Maharashtra, India
• Deenanath Mangeshkar Hospital and Research Centre — Pune, Maharashtra, India
• G. Kuppuswamy Naidu Memorial Hospital — Pappanaickenpalayam, Coimbatore, Tamil Nadu, 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, Puerto Rico
• Fundacion de Investigacion de Diego — Santurce, Puerto Rico
• "Prof. Dr. Ion Chiricuţă" Institute of Oncology — Cluj-Napoca, Romania
• Clinical Emergency Hospital - Oncology Department — Constanța, Romania

Full record on ClinicalTrials.gov

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