Clareo Health | Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen
Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen
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Keep this study
Lead
Sanofi
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
The subject has pathologically and radiologically confirmed metastatic HER2 positive breast cancer (Stage IV disease). Subjects must have received and progressed on at least one prior trastuzumab-containing regimen for metastatic disease. For subjects in Arm 2, they must also have received at least one prior taxane-containing regimen.
The subject has at least one lesion that is not within a previously radiated field and measurable on computerized tomography (CT) or magnetic resonance imaging scan (MRI)
The subjects enrolled in Phase 2 must be willing to undergo a biopsy of the primary tumor or a tumor metastasis at baseline, if tumor tissue is amenable to biopsy
The subject's primary tumor and/or metastatic lesion must overexpress HER2
For subjects enrolled in Phase 2: samples from archival or fresh tissue, or a tissue block of the subject's tumor.
The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
The subject has adequate organ and marrow function
The subject is capable of understanding the informed consent and complying with the protocol and has signed the informed consent document prior to any study-specific screening procedures or evaluations being performed.
Sexually active subjects must agree to use a medically-accepted barrier method of contraception during the course of the study and for 3 months following discontinuation of study treatments. For subjects using oral contraceptives, a barrier method must be used in addition to the oral contraceptive
Subjects of childbearing potential must have a negative pregnancy test at screening and enrollment
You may not be if
The subject has previously been treated with a selective inhibitor of PI3K and / or AKT
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. Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥4 weeks prior to first study treatment
The subject has prothrombin time/International Normalized Ratio (PT/INR) or partial thromboplastin time (PTT) test results at screening that are ≥ 1.3 times above the laboratory upper limit of normal
The subject has a diagnosis of uncontrolled diabetes mellitus
The subject has uncontrolled significant intercurrent illness
The subject has uncontrolled hypertension or other clinically significant cardiovascular disease
The subject has left ventricular ejection fraction (LVEF) ≤ 50%
The subject has a baseline corrected QT interval ≥ 460 ms
The subject is currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day is permitted)
The subject is pregnant or breastfeeding
The subject is known to be positive for the human immunodeficiency virus (HIV) (a test for HIV at screening is not required)
The subject has any other diagnosis of malignancy or evidence of malignancy (except non-melanoma skin cancer, in situ carcinoma of the cervix) within 2 years prior to screening for this study
The subject has a previously identified allergy or hypersensitivity or is intolerant to components of any of the study treatment formulations
The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
