Solid tumors
Conditions
Interventions
investigational material(s)
Generic name etc : Cobimetinib
INN of investigational material : Cobimetinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
CHUGAI PHARMACEUTICAL CO., LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics NCI CTCAE | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy RECIST | — |
Countries
Japan
Outcome results
None listed