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
Heather Wakelee

Winston Chen and Phyllis Huang Professor

George A. Fisher Jr.
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    10% 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

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

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