A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered Daily in Patients With Locally Advanced or Metastatic Solid Tumors
Status: Recruiting
Phase:
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT00996892
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-309
This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of daily oral dosing of GDC-0973 and GDC-0941 administered in combination in patients with solid tumors.
Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute
Overall PI:
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Linda Pointon, 617-632-4391,
linda_pointon@dfci.harvard.edu
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically documented, locally advanced or metastatic solid
tumors for which standard therapy either does not exist or has 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
- Agreement to use an effective form of contraception for the duration of the study
Exclusion Criteria
- History of prior significant toxicity from another MEK pathway inhibitor requiring
discontinuation of treatment
- History of prior significant toxicity from another PI3K pathway inhibitor requiring
discontinuation of treatment
- Allergy or hypersensitivity to components of the GDC-0973 or GDC-0941 formulations
- Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in
Cycle 1
- Experimental therapy within 4 weeks prior to first dose of study drug treatment in
Cycle 1
- Major surgical procedure or significant traumatic injury within 4 weeks prior to
first dose of study drug treatment in Cycle 1, or anticipation of the need for major
surgery during the course of study treatment
- Prior anti-cancer therapy within 28 days before the first dose of study drug
treatment in Cycle 1
- History of diabetes requiring daily medication, or history of Grade ≥ 3 fasting
hyperglycemia
- Current severe, uncontrolled systemic disease
- History of clinically significant cardiac or pulmonary dysfunction
- History of malabsorption or other condition that would interfere with enteral
absorption
- Clinically significant history of liver disease (including cirrhosis), current
alcohol abuse, or current known active infection with HIV, hepatitis B virus, or
hepatitis C virus
- Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
- Active autoimmune disease
- Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive
weeks prior to enrollment
- Pregnancy, lactation, or breastfeeding
- Known brain metastases that are untreated, symptomatic, or require therapy to control
symptoms
- No other history of or ongoing malignancy that would potentially interfere with the
interpretation of the pharmacodynamic or efficacy assays