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

NCT00560560 | Completed Phase 2 Results

• 1 other identifier: A4021006
• Study Type: interventional
• Target: 168
• Locations: 3 countries
• Sites: 12

Brief Summary

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

Conditions

Colorectal Neoplasm

Keywords

Refractory Colorectal; Single arm; Phase 2

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Overall Survival

  From date of enrollment until death or censorship, up to 33 months

• 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.

• 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

• 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

• 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)

Study Arms (1)

1

EXPERIMENTAL

Single arm study

Biological: CP-751, 871

Interventions

CP-751, 871 BIOLOGICAL

Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Pfizer Investigational Site

Elche, Alicante, 03202, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08003, Spain

Location

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Pfizer Investigational Site

Peterborough, Cambridgeshire, PE3 6DA, United Kingdom

Location

Pfizer Investigational Site

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Pfizer Investigational Site

Cardiff, CF14 2TL, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G12 0YN, United Kingdom

Location

Pfizer Investigational Site

Peterborough, PE3 6DA, United Kingdom

Location

Pfizer Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 19, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 20, 2013
• Results First Posted: May 9, 2013

Record last verified: 2013-05

Locations

US (2); ES (4); GB (6)