A Study of R547 in Patients With Advanced Solid Tumors.
- Registration Number
- NCT00400296
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- adult patients, >=18 years of age;
- locally advanced or metastatic solid tumors;
- measurable or evaluable disease.
Exclusion Criteria
- prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
- prior history of CNS metastases with disease progression;
- patients taking strong inhibitors and/or inducers of CYP3A4.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 RG547 -
- Primary Outcome Measures
Name Time Method AEs, laboratory parameters. Throughout study
- Secondary Outcome Measures
Name Time Method Pharmacokinetic and pharmacodynamic profiles of R547 Throughout study