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Status: RecruitingPhase: Diagnosis: Solid Tumor/Phase INCT ID: NCT01296555
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-010
This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally (PO) and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.
Conducting Institutions: Dana-Farber Cancer Institute, Massachusetts General Hospital
Overall PI: Ian Krop, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators: Jose Baselga M.D.,
Massachusetts General Hospital
Contacts: Dana-Farber Cancer Institute:
Linda Pointon, 617-632-4391,
firstname.lastname@example.orgMassachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100