A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors
Completed · Phase 1
Conditions studied: Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01562275
- Run by
- Genentech, Inc.
- People needed
- 67
- Starts
- 2012-04-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-03-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment
- History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) or Akt pathway or mammalian target of rapamycin (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
Where it is running
- Study site — Boston, Massachusetts, United States
- Study site — Detroit, Michigan, United States
- Study site — Nashville, Tennessee, United States
- Study site — Barcelona, Barcelona, Spain
- Study site — Valencia, Valencia, Spain
Full record on ClinicalTrials.gov
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