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A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasm

Thank you

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 SiteBlendora, California  91740
Pfizer Investigational SiteHouston, Texas  77030