Phase I Study of Cobimetinib as a Single Agent or in Combination with other Anticancer Agents in Patients with Advanced Solid Tumors
- Conditions
- Solid tumors
- Registration Number
- JPRN-jRCT2080223552
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 42
Advanced or recurrent cancer that is refractory or ineligible to standard therapy or for which no standard therapy exists.
- Histologically or cytologically confirmed solid tumor.
- ECOG PS of 0 or 1.
- Life expectancy >=12 weeks from the date of enrollment.
- Major organ function meets all criteria.
- Unable to take oral drugs or has a gastrointestinal disorder that would affect gastrointestinal drug absorption.
- Pregnant or lactating woman.
- Current or previous autoimmune disease.
- Positive test result for human immunodeficiency virus (HIV) antibody, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, or hepatitis C virus (HCV) antibody (eligible if HCV-RNA-negative).
- Current or previous clinically significant liver disease.
- Current or previous ophthalmologic findings that indicate a risk of retinal detachment, central serous chorioretinopathy, retinal vein occlusion, or macular degeneration.
- History of treatment with immune checkpoint inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>NCI CTCAE
- Secondary Outcome Measures
Name Time Method efficacy<br>RECIST