Status:
TERMINATED
Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib administered in combina...
Eligibility Criteria
Inclusion
- 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 greater than or equal to (\>=) 12 weeks
- Adequate hematologic and end organ function
- Agreement to use an effective form of contraception for the duration of the study
Exclusion
- History of prior significant toxicity from another mitogen-activated protein kinase (MEK) pathway inhibitor requiring discontinuation of treatment
- History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) pathway inhibitor requiring discontinuation of treatment
- Allergy or hypersensitivity to components of the cobimetinib or pictilisib 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 human immunodeficiency virus (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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00996892
Start Date
November 1 2009
End Date
March 1 2014
Last Update
December 30 2016
Active Locations (6)
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1
Baltimore, Maryland, United States, 21231
2
Boston, Massachusetts, United States, 02114
3
Boston, Massachusetts, United States, 02215
4
Detroit, Michigan, United States, 48201