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

Colorectal Neoplasm Clinical Trial

Official title:

A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560560
• Other study ID #: A4021006
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: May 16, 2013
• Start date: December 2007
• Est. completion date: September 2010

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Elche	Alicante
Spain	Pfizer Investigational Site	L'hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Sevilla
United Kingdom	Pfizer Investigational Site	Cardiff
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Leicester	Leicestershire
United Kingdom	Pfizer Investigational Site	Peterborough	Cambridgeshire
United Kingdom	Pfizer Investigational Site	Peterborough
United Kingdom	Pfizer Investigational Site	Southampton
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate of the 6 Month Survival Probability	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.	Baseline up to Month 6	No
Secondary	Overall Survival	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.	From date of enrollment until death or censorship, up to 33 months	No
Secondary	Progression-Free Survival (PFS)	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.	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.	No
Secondary	Percentage of Participants With Objective Response	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.	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	No
Secondary	Descriptive Summary of Figitumumab Concentration Versus Time	The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5	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	No
Secondary	Participants Reporting Positive for Total Anti-drug Antibodies (ADA)	The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.	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)	Yes
Secondary	Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)	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.	Cycle 1 pre-dosing and Cycle 4 pre-dosing	No
Secondary	Counts of Circulating Tumor Cells (CTCs)	The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.	Cycle 1 pre-dosing and Cycle 4 pre-dosing	No

External Links

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