A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
18 Years
N/A
Both
Colorectal Neoplasm
Trial Information
A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Estimate of the 6 Month Survival Probability
Outcome Description:
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.
Outcome Time Frame:
Baseline up to Month 6
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4021006
NCT ID:
NCT00560560
Start Date:
December 2007
Completion Date:
September 2010
Related Keywords:
- Colorectal Neoplasm
- Refractory Colorectal
- Single arm
- Phase 2
- Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Houston, Texas 77030 |
