Study of Cobimetinib in Participants With Solid Tumors
Trial ID or NCT#
NCT00467779
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0973/XL518 Administered Orally Daily to Subjects With Solid Tumors
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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 Grade \
Investigator(s)
George A. Fisher Jr.
Medical oncologist,
Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
