Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments
NCT00560560
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Adult Trials: 18+ Years
- 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
- 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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| 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 | 168 | |||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||