A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01562275 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-145


This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Daniel Cho, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically documented locally advanced or metastatic solid tumors for which standard therapies either do not exist or have proven ineffective or intolerable - Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST) - Life expectancy >/= 12 weeks - Adequate hematologic and end organ function Exclusion Criteria: - History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment - History of prior significant toxicity from another PI3K or Akt pathway or mTOR inhibitor requiring discontinuation of treatment - Anti-cancer therapy within 28 days prior to first dose of study drug, except as stated in protocol - History of type I or type II diabetes mellitus requiring insulin - Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) - Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, hepatitis B or hepatitis C virus - Active autoimmune disease - Pregnant or lactating women - Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms - History of glaucoma - History of retinal vein occlusion
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