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