Study of XL147 (SAR245408) or XL765 (SAR245409) in Combination With Letrozole in Subjects With Breast Cancer
NCT ID: NCT01082068
Last Updated: 2016-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2010-06-30
2013-04-30
Brief Summary
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Upregulation of PI3K activity is one of the most common characteristics of human cancer cells, including breast tumor cells. Activation of PI3K results in stimulation of AKT and mTOR kinases, resulting in the promotion of tumor cell proliferation and survival. Preclinical and retrospective clinical data suggest that aberrant activation of the PI3K pathway may play a role in aromatase inhibitor resistance in patients with ER+, HER2- breast cancer. XL147 is a potent inhibitor of PI3K, and XL765 is a potent dual inhibitor of PI3K and mTOR; therefore either of these compounds in combination with letrozole warrants clinical investigation.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
XL147 (SAR245408) + letrozole
XL147 (SAR245408)
given orally once daily as tablets
letrozole (Femara)
given orally once daily as tablets
Arm 2
XL765 + letrozole
XL765 (SAR245409)
given orally twice daily as capsules
letrozole (Femara)
given orally once daily as tablets
Interventions
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XL147 (SAR245408)
given orally once daily as tablets
XL765 (SAR245409)
given orally twice daily as capsules
letrozole (Femara)
given orally once daily as tablets
Eligibility Criteria
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Inclusion Criteria
* The subject's breast cancer is negative for HER2.
* The subject has recurrent or metastatic breast cancer that is refractory to a nonsteroidal aromatase inhibitor and has either disease progression or disease recurrence.
* Subjects previously treated with letrozole must be able to tolerate the approved dose and schedule of letrozole.
* For subjects enrolled in Phase 2, either archival tumor samples must be available, or the subject must be willing to undergo a fresh biopsy.
* In Phase 2, at least 30 subjects in each arm must have measurable disease
* The subject is a postmenopausal female.
* If a subject is currently receiving bisphosphonates, the subject must have received the bisphosphonates for at least 2 months before starting study treatment.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
* The subject has adequate organ and marrow function.
* The subject has no other diagnosis of malignancy or evidence of other malignancy for 2 years before screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).
* The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
Exclusion Criteria
* Certain restrictions on prior therapies apply.
* The subject has not recovered from toxicity due to prior therapy to Grade ≤ 1 or to pre-therapy baseline.
* The subject has untreated, symptomatic, or progressive brain metastases.
* The subject has only non-measurable lesions, other than bone, skin, or chest wall metastasis
* The subject has to start cytotoxic chemotherapy due to rapid progressive disease involving major organs.
* The subject has prothrombin time/ International Normalized Ratio (PT/ INR) or partial thromboplastin time (PTT) test results at screening that are above 1.3 x the laboratory upper limit of normal.
* The subject has uncontrolled significant intercurrent illness.
* The subject has a baseline corrected QT interval (QTc) \> 470 ms.
* The subject has a diagnosis of uncontrolled diabetes mellitus.
* The subject is known to be positive for the human immunodeficiency virus (HIV).
* The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation(s).
* The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
18 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 1537
Los Angeles, California, United States
Investigational Site Number 1601
Denver, Colorado, United States
Investigational Site Number 1238
Fort Meyers, Florida, United States
Investigational Site Number 1441
Chicago, Illinois, United States
Investigational Site Number 1138
Boston, Massachusetts, United States
Investigational Site Number 1331
Ann Arbor, Michigan, United States
Investigational Site Number 1330
Detroit, Michigan, United States
Investigational Site Number 5201
Columbia, Missouri, United States
Investigational Site Number 1252
Durham, North Carolina, United States
Investigational Site Number 1214
Nashville, Tennessee, United States
Investigational Site Number 5246
El Paso, Texas, United States
Investigational Site Number 3321
Nantes Saint Herblain, , France
Investigational Site Number 3324
Paris, , France
Investigational Site Number 3415
Barcelona, , Spain
Investigational Site Number 3419
Barcelona, , Spain
Investigational Site Number 3413
Madrid, , Spain
Investigational Site Number 3420
Madrid, , Spain
Countries
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Other Identifiers
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XL147-202
Identifier Type: OTHER
Identifier Source: secondary_id
ARD11437
Identifier Type: -
Identifier Source: org_study_id
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