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

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NCT01420081

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Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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Contact
1-800-718-1021
[email protected]
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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

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Endometrial NeoplasmsA Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
NCT01420081
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. La Jolla, California
  5. La Jolla, California
  6. San Diego, California
  7. Miami, Florida
  8. Miami, Florida
  9. Chicago, Illinois
  10. New Lenox, Illinois
  11. Fairway, Kansas
  12. Kansas City, Kansas
  13. Westwood, Kansas
  14. Covington, Louisiana
  15. Covington, Louisiana
  16. Metairie, Louisiana
  17. Boston, Massachusetts
  18. Boston, Massachusetts
  19. Boston, Massachusetts
  20. Ann Arbor, Michigan
  21. Albuquerque, New Mexico
  22. East Melbourne, Victoria
  23. Calgary, Alberta
  24. Calgary, Alberta
  25. Vancouver, British Columbia
  26. Kingston, Ontario
  27. Toronto, Ontario
  28. Montreal, Quebec
  29. Montreal, Quebec
  30. Montreal, Quebec
  31. Nagoya, Aichi
  32. Akashi, Hyogo
  33. Hidaka, Saitama
  34. Chuo-Ku, Tokyo
  35. Lodz,
  36. Lodz,
  37. Lublin,
  38. Lermontov, Stavropol Territory
  39. Krasnodar,
  40. Pyatigorsk,
  41. Saint Petersburg,
  42. Barcelona,
  43. Madrid,
  44. Madrid,
  45. Madrid,
  46. Valencia,
  47. Valencia,
  48. Sutton, Surrey
  49. Glasgow,
  50. London,
  51. London,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
Official Title  ICMJE A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Neoplasms
Intervention  ICMJE Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 11, 2015)		67
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2011)		252
Actual Study Completion Date  ICMJE December 25, 2015
Actual Primary Completion Date April 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Japan,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries Germany,   Slovakia
 
Administrative Information
NCT Number  ICMJE NCT01420081
Other Study ID Numbers  ICMJE B1271004
2011-003062-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP