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

Last updated on August 9, 2018

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Study Location
Contact
1-800-718-1021
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

NCT01658176
Pfizer
Withdrawn
Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer

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Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • 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
  • Experimental: PF-04691502 + Exemestane
    PF-04691502 in combination with Exemestane
    Interventions:
    • Drug: PF-04691502
    • Drug: Exemestane
  • Active Comparator: Exemestane
    Exemestane alone
    Intervention: Drug: Exemestane
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01658176
B1271005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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