Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumors

In brief

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 combination in patients with locally advanced or metastatic solid tumors.

Key facts

Study ID

NCT00996892

Run by

Genentech, Inc.

People needed

178

Starts

2009-11-01

Expected to finish

2014-03-01

Last updated by the study team

2016-12-30

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 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

You may not qualify if…

• 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

Where it is running

• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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