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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


Phase 2
20 Years
N/A
Open (Enrolling)
Female
Endometrial Neoplasms

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Trial Information

A Randomized Phase 2 Non-Comparative Study Of The Efficacy Of PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Clinical Benefit Response (CBR)

Outcome Time Frame:

16

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:

B1271004

NCT ID:

NCT01420081

Start Date:

January 2012

Completion Date:

May 2014

Related Keywords:

  • Endometrial Neoplasms
  • uterine neoplasms
  • endometrial
  • uterine
  • cancer
  • PI3K
  • mTOR
  • PI3K/mTOR
  • recurrent
  • metastatic
  • Neoplasms
  • Endometrial Neoplasms
  • Adenoma

Name

Location
Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Santa Fe, New Mexico  87505
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Shreveport, Louisiana  71103