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Study of Cobimetinib in Participants With Solid Tumors
Not Recruiting
Trial ID: NCT00467779
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
Stanford Investigator(s)
Heather Wakelee
Winston Chen and Phyllis Huang Professor
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Eligibility
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 \* 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
Intervention(s):
drug: midazolam
drug: dextromethorphan
drug: cobimetinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061