Breast NeoplasmsPhase 2NCT01658176
Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer
A Phase 2 study testing PF-04691502 and Exemestane in people with Breast Neoplasms, run by Pfizer.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- PF-04691502 and Exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
- Conditions
- Breast Neoplasms
- Being tested
- PF-04691502, Exemestane
- Keywords
- Estrogen receptor positive, Her-2 negative, advanced breast cancer, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04691502Drug
PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule
ExemestaneDrug
Exemestane administered orally at 25 mg as a continuous daily dosing schedule
ExemestaneDrug
Exemestane administered orally at 25 mg as a continuous daily dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| PF-04691502 + Exemestane | Experimental | PF-04691502 in combination with Exemestane Receives: Drug: PF-04691502; Drug: Exemestane |
| Exemestane | Active comparator | Exemestane alone Receives: Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: Baseline up to month 12
Secondary outcomes (13)
Objective tumor response using RECIST
Measured: Baseline up to month 12
Duration of tumor response
Measured: Baseline up to month 12
Clinical benefit response
Measured: Baseline up to month 12
Overall Survival
Measured: 2 years
Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue
Measured: Baseline
Maximum concentration (Cmax) of single dose of PF-04691502
Measured: Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose
Maximum concentration (Cmax) of single dose exemestane
Measured: 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
Measured: 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
Measured: 12 months
Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast
Measured: 12 months
Area under the plasma concentration versus time curve (AUC) of single dose of PF-04691502
Measured: 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
Measured: 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
Measured: Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658176
- Sponsor's protocol ID
- B1271005
- Status last verified
- Oct 2012
- First submitted
- 16 Jul 2012
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01658176
- Acronym / sponsor ID
- B1271005
- Conditions
- Breast Neoplasms
- Keywords
- Estrogen receptor positive, Her-2 negative, advanced breast cancer, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04691502 + Exemestane | Experimental | Drug: PF-04691502, Drug: ExemestanePF-04691502 in combination with Exemestane |
| Exemestane | Active comparator | Drug: ExemestaneExemestane alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-04691502PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule | Drug | PF-04691502 + Exemestane |
| ExemestaneExemestane administered orally at 25 mg as a continuous daily dosing schedule | Drug | PF-04691502 + Exemestane |
| ExemestaneExemestane administered orally at 25 mg as a continuous daily dosing schedule | Drug | Exemestane |
Primary outcome
Progression-Free Survival
Time frame: Baseline up to month 12
13 secondary outcomes
Objective tumor response using RECIST
Time frame: Baseline up to month 12
Duration of tumor response
Time frame: Baseline up to month 12
Clinical benefit response
Time frame: Baseline up to month 12
Overall Survival
Time frame: 2 years
Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue
Time frame: Baseline
Maximum concentration (Cmax) of single dose of PF-04691502
Time frame: Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose
Maximum concentration (Cmax) of single dose exemestane
Time frame: 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
Time frame: 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
Time frame: 12 months
Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast
Time frame: 12 months
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-04691502 and Exemestane in people with Breast Neoplasms, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: Baseline up to month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.