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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01658176
Recruitment Status : Withdrawn
First Posted : August 6, 2012
Last Update Posted : October 29, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: PF-04691502 Drug: Exemestane Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane

Arm Intervention/treatment
Experimental: PF-04691502 + Exemestane
PF-04691502 in combination with Exemestane
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

Active Comparator: Exemestane
Exemestane alone
Drug: Exemestane
Exemestane administered orally at 25 mg as a continuous daily dosing schedule




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: Baseline up to month 12 ]

Secondary Outcome Measures :
  1. Objective tumor response using RECIST [ Time Frame: Baseline up to month 12 ]
  2. Duration of tumor response [ Time Frame: Baseline up to month 12 ]
  3. Clinical benefit response [ Time Frame: Baseline up to month 12 ]
  4. Overall Survival [ Time Frame: 2 years ]
  5. Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue [ Time Frame: Baseline ]
  6. Maximum concentration (Cmax) of single dose of PF-04691502 [ Time Frame: Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose ]
  7. Maximum concentration (Cmax) of single dose exemestane [ Time Frame: Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose ]
  8. 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 ]
  9. Pharmacodynamic endpoints including serum glucose, insulin, HbA1c, cholesterol and triglycerides [ Time Frame: 12 months ]
  10. Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast [ Time Frame: 12 months ]
  11. 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 ]
  12. 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 ]
  13. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658176


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01658176    
Other Study ID Numbers: B1271005
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012
Keywords provided by Pfizer:
Estrogen receptor positive
Her-2 negative
advanced breast cancer
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sirolimus
Exemestane
Everolimus
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents