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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00560560
First received: November 15, 2007
Last updated: May 16, 2013
Last verified: May 2013

November 15, 2007
May 16, 2013
December 2007
September 2010   (final data collection date for primary outcome measure)
Estimate of the 6 Month Survival Probability [ Time Frame: Baseline up to Month 6 ] [ Designated as safety issue: No ]
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.
Six-month Survival
Complete list of historical versions of study NCT00560560 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: From date of enrollment until death or censorship, up to 33 months ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.
  • � Safety and tolerability
  • � Progression free survival
Not Provided
Not Provided
 
Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments
A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum

This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Neoplasm
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.
Experimental: 1
Single arm study
Intervention: Biological: CP-751, 871
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   United Kingdom
 
NCT00560560
A4021006
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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