NCT01658176

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

2.2 years

First QC Date

July 16, 2012

Last Update Submit

October 26, 2012

Conditions

Breast Neoplasms

Keywords

Estrogen receptor positiveHer-2 negativeadvanced breast cancerBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival

    Baseline up to month 12

Secondary Outcomes (13)

  • Objective tumor response using RECIST

    Baseline up to month 12

  • Duration of tumor response

    Baseline up to month 12

  • Clinical benefit response

    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

  • +8 more secondary outcomes

Study Arms (2)

PF-04691502 + Exemestane

EXPERIMENTAL

PF-04691502 in combination with Exemestane

Drug: PF-04691502Drug: Exemestane

Exemestane

ACTIVE COMPARATOR

Exemestane alone

Drug: Exemestane

Interventions

PF-04691502DRUG

PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule

PF-04691502 + Exemestane
ExemestaneDRUG

Exemestane administered orally at 25 mg as a continuous daily dosing schedule

PF-04691502 + Exemestane

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

2-amino-8-(4-(2-hydroxyethoxy)cyclohexyl)-6-(6-methoxypyridin-3-yl)-4-methylpyrido(2,3-d)pyrimidin-7(8H)-oneexemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2012

First Posted

August 6, 2012

Study Start

January 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 29, 2012

Record last verified: 2012-10