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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 SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteShreveport, Louisiana  71103