drugset / Trial / NCT00725634
A Phase 1 Dose-Escalation Study in Advanced Solid Tumors, Lymphomas or Multiple Myeloma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Phase 1 study to determine safety, tolerability, dose-limiting toxicities (DLTs), and recommended Phase 2 dose of AV-299 administered IV as monotherapy to patients with relapsed or refractory solid tumors, lymphoma, or multiple myeloma. The study will also determine the safety, tolerability and DLTs of AV-299 in combination with erlotinib in patients with relapsed or refractory solid tumors.
Timeline
- Start
- 2008-09
- Primary completion
- 2010-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ficlatuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Ficlatuzumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Ficlatuzumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Ficlatuzumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Erlotinib | Small molecule | 150 mg | — |