Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer

NCT01658176

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast 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

- Inoperable estrogen receptor positive, Her-2 negative advanced breast cancer

- Previously treated with an aromatase inhibitor

- Primary or secondary hormone resistance

- Acceptable glucose control, bone marrow, liver and kidney function

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


- Inflammatory breast carcinoma


- Prior therapy with an agent active on PI3K, Akt, and/or mTOR


- Known hypersensitivity to exemestane


- Significant gastrointestinal abnormalities which may impair intake, transit, or
absorption of the study drugs


- Current or anticipated need for food or drugs that are known inhibitors or inducers of
CYP3A4

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer
Official Title  ICMJE An Open-Label Randomized Phase 2 Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Advanced Breast Cancer
Brief Summary PF-04691502 is an inhibitor of PI3K and mTOR kinase. Exemestane is an aromatase inhibitor for the treatment of advanced breast cancer in women whose disease has progressed following tamoxifen therapy. The combination of PF-04691502 and exemestane might mitigate resistance to hormonal therapy and result in greater clinical benefit than exemestane alone in women with estrogen receptor positive advanced breast cancer.
Detailed Description Not Provided
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 Breast Neoplasms
Intervention  ICMJE
  • Drug: PF-04691502
    PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule
  • Drug: Exemestane
    Exemestane administered orally at 25 mg as a continuous daily dosing schedule
Study Arms  ICMJE
  • Experimental: PF-04691502 + Exemestane
    PF-04691502 in combination with Exemestane
    Interventions:
    • Drug: PF-04691502
    • Drug: Exemestane
  • Active Comparator: Exemestane
    Exemestane alone
    Intervention: Drug: Exemestane
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 26, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2012)
128
Estimated Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Inoperable estrogen receptor positive, Her-2 negative advanced breast cancer
  • Previously treated with an aromatase inhibitor
  • Primary or secondary hormone resistance
  • Acceptable glucose control, bone marrow, liver and kidney function

Exclusion Criteria:

  • Inflammatory breast carcinoma
  • Prior therapy with an agent active on PI3K, Akt, and/or mTOR
  • Known hypersensitivity to exemestane
  • Significant gastrointestinal abnormalities which may impair intake, transit, or absorption of the study drugs
  • Current or anticipated need for food or drugs that are known inhibitors or inducers of CYP3A4
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01658176
Other Study ID Numbers  ICMJE B1271005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 October 2012

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