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

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NCT01420081

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
See other locations
Contact
1-800-718-1021
Clinic[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endometrial Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01420081
Pfizer
Terminated
A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

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A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Endometrial Neoplasms
Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587
  • Experimental: B
    PI3K Basal, IV Compound
    Intervention: Drug: PF-05212384
  • Experimental: C
    PI3K Activated, Oral Compound
    Intervention: Drug: PF-05212384
  • Experimental: F
    Japanese lead in cohort, IV compound
    Intervention: Drug: PF-05212384
Del Campo JM, Birrer M, Davis C, Fujiwara K, Gollerkeri A, Gore M, Houk B, Lau S, Poveda A, González-Martín A, Muller C, Muro K, Pierce K, Suzuki M, Vermette J, Oza A. A randomized phase II non-comparative study of PF-04691502 and gedatolisib (PF-05212384) in patients with recurrent endometrial cancer. Gynecol Oncol. 2016 Jul;142(1):62-69. doi: 10.1016/j.ygyno.2016.04.019. Epub 2016 Apr 24.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
67
December 25, 2015
April 30, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Japan,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
Germany,   Slovakia
 
NCT01420081
B1271004
2011-003062-32 ( EudraCT Number )
No
Not Provided
Plan to Share IPD: No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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