NCT00725634

A Phase 1 Dose-Escalation Study in Advanced Solid Tumors, Lymphomas or Multiple Myeloma

A Phase 1 Study of AV-299 (Formerly SCH 900105) Administered by IV Infusion as Monotherapy in Advanced Solid Tumors, Lymphomas, or Multiple Myeloma or in Combination With Erlotinib in Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Solid Tumor
• Lymphomas
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	AV-299	AV-299 monotherapy will be given as intravenous infusion in dose-escalation cohorts at 2, 5, 10, and 20 mg/kg. Once the RP2D has been determined the cohort may be expanded to include up to 12 patients for safety assessment and enriched with up to 12 additional Multiple Myeloma patients.
BIOLOGICAL	AV-299 + erlotinib	AV-299 will be given as intravenous infusion at RP2D in combination with erlotinib (150 mg daily). Once the combination-RP2D has been determined the cohort may be expanded to include up to 12 additional patients.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-12-01
• Completion: 2013-12-01
• First posted: 2008-07-30
• Last updated: 2014-01-27

Locations

3 sites across 1 country: United States