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
Phase:
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
Contacts:
Dana-Farber Cancer Institute:
Linda Pointon, 617-632-4391,
linda_pointon@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