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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

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NCT00560560

Last updated on February 18, 2020
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Study Location
Pfizer Investigational Site
San Francisco, California, 94115 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasm
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00560560
Pfizer
Completed
Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

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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

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Pfizer Clinical Trials Contact Center

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