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Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00890305•Medivation, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient's age is 18 years or older, both genders.
•2. 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.
•3. ECOG performance status ≤ 1
•4. At least 4 weeks from prior major surgery or radiotherapy.
•5. Life expectancy \>3 months
•6. Hematology: ANC ≥ 1.5X109/L; Platelets \>100x109/L.
•7. Adequate Renal function
•8. Adequate Hepatic functions
•9. Normal Cardiac function

Exclusion Criteria

•1. Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
•2. Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
•3. Patients on concurrent anti cancer therapy other than that allowed in the study.
•4. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
•5. Presence of clinically apparent or suspected brain metastasis.
•6. Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
•7. Serious active infection at the time of pre-study screening.
•8. Active or history of autoimmune disorders/conditions.
•9. Women who are pregnant or lactating
•10. Concurrent active malignancy.
+6 more criteria

Locations (31)

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

Key Dates

Start Date

May 1, 2009

Primary Completion Date

May 1, 2012

Completion Date

March 1, 2013

Last Updated

July 8, 2015

Enrollment

171

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

CT-011

DRUG

FOLFOX

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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