drugset / Trial / NCT01605526
A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
Timeline
- Start
- 2012-05
- Primary completion
- 2013-06
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | RO5045337 | Small molecule | — | Oral |