Study of Cobimetinib in Participants With Solid Tumors

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This non-randomized, open-label, study will determine the highest safe dose of cobimetinib, how often it should be taken, how well participants with cancer tolerate cobimetinib and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Dextromethorphan; Midazolam

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival

• Disease that is measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)

• Adequate organ and marrow function

• Sexually active participants must use medically acceptable methods of contraception during the course of the study and at least 11 days after the last dose of study treatment

• Female participants of childbearing potential must have a negative serum pregnancy test at screening

• No other history of/or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays

Exclusion Criteria:

• Anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study drug

• The participant has not recovered to Grade10% of baseline values due to investigational or other agents administered more than 28 days prior to study enrollment

• The participant has received another investigational agent within 28 days of the first dose of study drug

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

• The participant is pregnant or breastfeeding

• The participant is known to be positive for the human immunodeficiency virus (HIV)

• Allergy or hypersensitivity to components of the cobimetinib formulation