A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer



Status:Terminated
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:January 19, 2012
End Date:December 25, 2015

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A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER

This study will investigate the individual safety and efficacy of two dual PI3K/mTOR
inhibitors in patients with recurrent endometrial cancer.

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 decision to terminate the study was made on January 23, 2014. It should be
noted that safety concerns have not been seen in this study and have not factored into this
decision.

Inclusion Criteria:

- 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 Criteria:

- 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
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5841 S Maryland Ave
Chicago, Illinois 60637
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1201 Camino de Salud Northeast
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1720 2nd Ave S
Birmingham, Alabama 35233
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185 Cambridge Street
Boston, Massachusetts 02114
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75 Francis street
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500 S State St
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