drugset / Trial / NCT00890955
Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies
Phase 1
Completed
36 enrolled
Lawrence Einhorn
Celgene Corporation · collabHoosier Cancer Research Network · collab
NaSingle-groupOpen-labelTreatment
Summary
Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful. This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in relapsed solid tumors and will define the MTD of the combination in a US population.
Timeline
- Start
- 2009-03
- Primary completion
- 2010-07
- Completion
- 2010-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amrubicin | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Amrubicin | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Amrubicin | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Amrubicin | Small molecule | 35 mg/m2 | Intravenous |
| Subject | Amrubicin | Small molecule | 40 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |