A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01296555 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-010


This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0032 administered every day orally (PO).


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

Dana-Farber Cancer Institute: Linda Pointon, 617-632-4391, linda_pointon@dfci.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically documented, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit - Evaluable or measurable disease per RECIST v1.1 - Life expectancy of >= 12 weeks - Adequate hematologic and organ function within 14 days prior to initiation of study treatment - Documented willingness to use an effective means of contraception for both men and women while participating in the study Exclusion Criteria: - Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months prior to initiation of study treatment - History of Type 1 or 2 diabetes requiring daily medication - Grade >=2 peripheral neuropathy - Active congestive heart failure or ventricular arrhythmia requiring medication - Patients requiring any daily supplemental oxygen - Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis - Treatment with chemotherapy ≤ 4 weeks before study treatment - Treatment with investigational drug ≤ 4 weeks before study treatment - Treatment with biologic therapy ≤ 4 weeks before study treatment - Treatment with kinase inhibitors ≤ 2 weeks before study treatment - Radiation therapy ≤ 4 weeks before study treatment - Radiation therapy for bony metastases ≤ 2 weeks before study treatment; other radiation for cancer therapy ≤ 4 weeks before study treatment - Major surgery ≤ 4 weeks before study treatment - Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications
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