This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Houston, Texas, United States
MTD and associated dose schedule
Time frame: Every 28 days
Clinical response
Time frame: Event driven
Dose-limiting toxicities.
Time frame: Throughout study
Pharmacokinetic profile
Time frame: Throughout study
Comparison safety and tolerability of daily versus twice daily dosing regimens
Time frame: approximately 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
San Antonio, Texas, United States
Unnamed facility
Bordeaux, France
Unnamed facility
Lyon, France