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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01658176
• Other study ID #: B1271005
• Status: Withdrawn
• Phase: Phase 2
• First received: July 16, 2012
• Last updated: October 26, 2012
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: October 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• PF-04691502
PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule
• Exemestane
Exemestane administered orally at 25 mg as a continuous daily dosing schedule
• Exemestane
Exemestane administered orally at 25 mg as a continuous daily dosing schedule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival		Baseline up to month 12	No
Secondary	Objective tumor response using RECIST		Baseline up to month 12	No
Secondary	Duration of tumor response		Baseline up to month 12	No
Secondary	Clinical benefit response		Baseline up to month 12	No
Secondary	Overall Survival		2 years	No
Secondary	Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue		Baseline	No
Secondary	Maximum concentration (Cmax) of single dose of PF-04691502		Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose	No
Secondary	Maximum concentration (Cmax) of single dose exemestane		Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose	No
Secondary	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	No
Secondary	Pharmacodynamic endpoints including serum glucose, insulin, HbA1c, cholesterol and triglycerides		12 months	No
Secondary	Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast		12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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