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Trial record 1 of 1 for:    NCT00560560
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Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

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.
 
ClinicalTrials.gov Identifier: NCT00560560
Recruitment Status : Completed
First Posted : November 19, 2007
Results First Posted : May 9, 2013
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 15, 2007
First Posted Date  ICMJE November 19, 2007
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE May 9, 2013
Last Update Posted Date May 20, 2013
Study Start Date  ICMJE December 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
Estimate of the 6 Month Survival Probability [ Time Frame: Baseline up to Month 6 ]
The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2007)
Six-month Survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
  • Overall Survival [ Time Frame: From date of enrollment until death or censorship, up to 33 months ]
    The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.
  • Progression-Free Survival (PFS) [ Time Frame: Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up. ]
    The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.
  • Percentage of Participants With Objective Response [ Time Frame: Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months ]
    Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.
  • Descriptive Summary of Figitumumab Concentration Versus Time [ Time Frame: Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5 ]
    The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5
  • Participants Reporting Positive for Total Anti-drug Antibodies (ADA) [ Time Frame: Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion) ]
    The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.
  • Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R) [ Time Frame: Cycle 1 pre-dosing and Cycle 4 pre-dosing ]
    The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.
  • Counts of Circulating Tumor Cells (CTCs) [ Time Frame: Cycle 1 pre-dosing and Cycle 4 pre-dosing ]
    The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2007)
  • � Safety and tolerability
  • � Progression free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments
Official Title  ICMJE A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
Brief Summary This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasm
Intervention  ICMJE Biological: CP-751, 871
Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.
Study Arms  ICMJE Experimental: 1
Single arm study
Intervention: Biological: CP-751, 871
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: November 20, 2012)
168
Original Enrollment  ICMJE
 (submitted: November 15, 2007)
80
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have stage IV colorectal cancer
  • Patients whose disease has worsened despite prior anti-cancer therapy
  • Patients who have satisfactory bonemarrow, kidney and liver function

Exclusion Criteria:

  • Patients who are being simultaneously treated with another anti-cancer therapy.
  • Patients who have previously received anti-cancer therapy that works like CP-751, 871 (targets insulin-like growth factor receptor)
  • Patients that are pregnant or breast-feeding
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 Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00560560
Other Study ID Numbers  ICMJE A4021006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2013

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