Status:
TERMINATED
A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
Lead Sponsor:
Pfizer
Conditions:
Endometrial Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.
Detailed Description
The study was prematurely discontinued due to lack confidence in the Stathmin assay as a patient selection criteria and subsequent lack of confidence in the efficacy signal that was observed. The deci...
Eligibility Criteria
Inclusion
- Recurrent endometrial carcinoma
- Disease progression following one or two lines of prior treatment with platinum containing chemotherapy
- Tumor tissue available at time of screening for PI3K analysis
- Adequate performance status
- Adequate glucose control, bone marrow, kidney, liver, and heart function
Exclusion
- More than 2 prior cytotoxic chemo regimens for endometrial carcinoma
- Prior therapy with an agent known to be a PI3K, and or mTOR and or AKT inhibitor
- Active brain metastases
Key Trial Info
Start Date :
January 19 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2015
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01420081
Start Date
January 19 2012
End Date
December 25 2015
Last Update
January 8 2019
Active Locations (51)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States, 35249
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
4
University of California Medical Center
La Jolla, California, United States, 92037