Back to resultsStudy Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer
Primary Purpose
Breast Neoplasms
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PF-04691502
Exemestane
Exemestane
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Estrogen receptor positive, Her-2 negative, advanced breast cancer, Breast Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PF-04691502 + Exemestane
Exemestane
Arm Description
PF-04691502 in combination with Exemestane
Exemestane alone
Outcomes
Primary Outcome Measures
Progression-Free Survival
Secondary Outcome Measures
Objective tumor response using RECIST
Duration of tumor response
Clinical benefit response
Overall Survival
Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue
Maximum concentration (Cmax) of single dose of PF-04691502
Maximum concentration (Cmax) of single dose exemestane
Maximum concentration (Cmax) of PF-04691502 and exemestane when administered in combination
Pharmacodynamic endpoints including serum glucose, insulin, HbA1c, cholesterol and triglycerides
Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast
Area under the plasma concentration versus time curve (AUC) of single dose of PF-04691502
Area under the plasma concentration versus time curve (AUC) of single dose exemestane
Area under the plasma concentration versus time curve (AUC) of PF-04691502 and exemestane when administered in combination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01658176
Brief Title
Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Withdrawn
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Estrogen receptor positive, Her-2 negative, advanced breast cancer, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04691502 + Exemestane
Arm Type
Experimental
Arm Description
PF-04691502 in combination with Exemestane
Arm Title
Exemestane
Arm Type
Active Comparator
Arm Description
Exemestane alone
Intervention Type
Drug
Intervention Name(s)
PF-04691502
Intervention Description
PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule
Intervention Type
Drug
Intervention Name(s)
Exemestane
Intervention Description
Exemestane administered orally at 25 mg as a continuous daily dosing schedule
Intervention Type
Drug
Intervention Name(s)
Exemestane
Intervention Description
Exemestane administered orally at 25 mg as a continuous daily dosing schedule
Primary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
Baseline up to month 12
Secondary Outcome Measure Information:
Title
Objective tumor response using RECIST
Time Frame
Baseline up to month 12
Title
Duration of tumor response
Time Frame
Baseline up to month 12
Title
Clinical benefit response
Time Frame
Baseline up to month 12
Title
Overall Survival
Time Frame
2 years
Title
Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue
Time Frame
Baseline
Title
Maximum concentration (Cmax) of single dose of PF-04691502
Time Frame
Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose
Title
Maximum concentration (Cmax) of single dose exemestane
Time Frame
Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose
Title
Maximum concentration (Cmax) of PF-04691502 and exemestane when administered in combination
Time Frame
Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25
Title
Pharmacodynamic endpoints including serum glucose, insulin, HbA1c, cholesterol and triglycerides
Time Frame
12 months
Title
Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast
Time Frame
12 months
Title
Area under the plasma concentration versus time curve (AUC) of single dose of PF-04691502
Time Frame
Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose
Title
Area under the plasma concentration versus time curve (AUC) of single dose exemestane
Time Frame
Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose
Title
Area under the plasma concentration versus time curve (AUC) of PF-04691502 and exemestane when administered in combination
Time Frame
Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1271005&StudyName=Study%20Of%20PF-04691502%20%28PI3K/mTOR%20Inhibitor%29%20In%20Combination%20With%20Exemestane%20Compared%20With%20Exemestane%20Alone%20In%20Patients%20with%20Advanced%20Breas
Description
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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
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