drugset / Trial / NCT00102609
A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
Phase 1
Completed
41 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar · collabPharmaMar S.A.U. · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.
Timeline
- Start
- 2005-04
- Primary completion
- —
- Completion
- 2007-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 0.9 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Intravenous |