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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00560560
First received: November 15, 2007
Last updated: May 16, 2013
Last verified: May 2013
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| Tracking Information | |||||
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| First Received Date ICMJE | November 15, 2007 | ||||
| Last Updated Date | May 16, 2013 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Six-month Survival | ||||
| Change History | Complete list of historical versions of study NCT00560560 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| 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. |
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| Study Arm (s) | Experimental: 1
Single arm study
Intervention: Biological: CP-751, 871 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 168 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Spain, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00560560 | ||||
| Other Study ID Numbers ICMJE | A4021006 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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