A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: RO5045337
- Registration Number
- NCT00559533
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
Inclusion Criteria
- adult patients, >=18 years of age;
- solid tumor malignancies;
- failed prior therapies, or no standard therapy available;
- ECOG performance status of 0-2.
Read More
Exclusion Criteria
- patients receiving any other agent or therapy to treat their malignancy;
- pre-existing gastrointestinal disorders which may interfere with absorption of drugs;
- clinically significant cardiovascular disease.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 RO5045337 -
- Primary Outcome Measures
Name Time Method MTD and associated dose schedule Every 28 days
- Secondary Outcome Measures
Name Time Method Clinical response Event driven Dose-limiting toxicities. Throughout study Pharmacokinetic profile Throughout study Comparison safety and tolerability of daily versus twice daily dosing regimens approximately 18 months