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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00890305
First Posted: April 29, 2009
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medivation, Inc.
April 28, 2009
April 29, 2009
July 8, 2015
May 2009
May 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00890305 on ClinicalTrials.gov Archive Site
  • Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011. [ Time Frame: 32 months ]
  • Anti tumor activity of the antibody. [ Time Frame: 32 months ]
  • Objective response rate by RECIST. [ Time Frame: 32 months ]
  • Progression-free survival rates. [ Time Frame: 32 months ]
  • Response duration. [ Time Frame: 32 months ]
  • Overall survival. [ Time Frame: 32 months ]
  • Tumor and immunological markers. [ Time Frame: 32 months ]
  • Safety, tolerability, pharmacokinetics and immunogenicity of CT-011. [ Time Frame: 32 months ]
  • Anti tumor activity of the antibody. [ Time Frame: 32 months ]
  • Objective response rate by RECIST. [ Time Frame: 32 months ]
  • Progression-free survival rates. [ Time Frame: 32 months ]
  • Response duration. [ Time Frame: 32 months ]
  • Overall survival. [ Time Frame: 32 months ]
  • Tumor and immunological markers. [ Time Frame: 32 months ]
Not Provided
Not Provided
 
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • Drug: CT-011
  • Drug: FOLFOX

    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).

  • Experimental: 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.

    Interventions:
    • Drug: CT-011
    • Drug: FOLFOX
  • Active Comparator: 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: Drug: FOLFOX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
March 2013
May 2012   (Final data collection date for primary outcome measure)

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.
  11. Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
  12. Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
  13. Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
  14. Patients with history of life threatening allergic reactions to food or drugs
  15. Patients with symptomatic peripheral neuropathy> Grade 1.
  16. Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   India,   Peru,   Puerto Rico,   Romania,   United States
 
 
NCT00890305
CT-2008-01
2009-014593-18 ( EudraCT Number )
Yes
Not Provided
Not Provided
Medivation, Inc.
Medivation, Inc.
Not Provided
Principal Investigator: Leonard B Saltz, MD Memorial Sloan Kettering Cancer Center
Medivation, Inc.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP