Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

Phase 2

Completed

• Conditions: Colorectal Neoplasm
• Interventions: Biological: CP-751, 871

• Registration Number: NCT00560560
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-19
• Study Start: 2007-12
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Disposition First Submitted: 2011-10-03
• Disposition First Submitted QC: 2011-10-03
• Disposition First Posted: 2011-10-05
• Results First Submitted: 2013-01-18
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-08
• Results First Posted: 2013-05-09
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CP-751, 871	Single arm study

Primary Outcome Measures

Name	Time	Method
Estimate of the 6 Month Survival Probability	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	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)	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	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	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)	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)	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)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Southampton, United Kingdom