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Trial record 1 of 1 for:    NCT00890305
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Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone

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ClinicalTrials.gov Identifier: NCT00890305
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.

Tracking Information
First Submitted Date  ICMJE April 28, 2009
First Posted Date  ICMJE April 29, 2009
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE May 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
Official Title  ICMJE 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
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • 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).

Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2013)
171
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2009)
168
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   India,   Peru,   Puerto Rico,   Romania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00890305
Other Study ID Numbers  ICMJE CT-2008-01
2009-014593-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medivation, Inc.
Study Sponsor  ICMJE Medivation, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonard B Saltz, MD Memorial Sloan Kettering Cancer Center
PRS Account Medivation, Inc.
Verification Date June 2015

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