Trial Information
An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
Inclusion Criteria:
- adult patients, >=18 years of age;
- advanced and/or metastatic cancer not amenable to standard therapy;
- any solid tumor type (Part 1); malignant melanoma or other responsive tumor type
(Part 2);
- measurable and/or evaluable disease (Part 1); >=1 measurable lesion (Part 2);
- ECOG performance status 0-2.
Exclusion Criteria:
- prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of
study drug;
- prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study
drug;
- active CNS lesions;
- acute or chronic infection.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (Part 1)
Outcome Time Frame:
Reviewed after each 4 week cycle
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Netherlands: Medicines Evaluation Board
Study ID:
BO21189
NCT ID:
NCT00817518
Start Date:
January 2009
Completion Date:
May 2013
Related Keywords: