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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04691502 + Exemestane | Experimental | PF-04691502 in combination with Exemestane |
|
| Exemestane | Active Comparator | Exemestane alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04691502 | Drug | PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Baseline up to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response using RECIST | Baseline up to month 12 | |
| Duration of tumor response | Baseline up to month 12 | |
| Clinical benefit response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C570662 | 2-amino-8-(4-(2-hydroxyethoxy)cyclohexyl)-6-(6-methoxypyridin-3-yl)-4-methylpyrido(2,3-d)pyrimidin-7(8H)-one |
| C056516 | exemestane |
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| Exemestane | Drug | Exemestane administered orally at 25 mg as a continuous daily dosing schedule |
|
| Exemestane | Drug | Exemestane administered orally at 25 mg as a continuous daily dosing schedule |
|
| Baseline up to month 12 |
| Overall Survival | 2 years |
| Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue | Baseline |
| Maximum concentration (Cmax) of single dose of PF-04691502 | Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose |
| Maximum concentration (Cmax) of single dose exemestane | Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose |
| Maximum concentration (Cmax) of PF-04691502 and exemestane when administered in combination | Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25 |
| Pharmacodynamic endpoints including serum glucose, insulin, HbA1c, cholesterol and triglycerides | 12 months |
| Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast | 12 months |
| Area under the plasma concentration versus time curve (AUC) of single dose of PF-04691502 | Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose |
| Area under the plasma concentration versus time curve (AUC) of single dose exemestane | Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose |
| Area under the plasma concentration versus time curve (AUC) of PF-04691502 and exemestane when administered in combination | Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25 |
| D017437 |
| Skin and Connective Tissue Diseases |