A Phase 1-2 Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With rhuMAb VEGF (Bevacizumab) in Patients With Locally Advanced or Metastatic Carcinoid Tumors

NCT00328497 Phase 2 COMPLETED

This single center, open-label study will evaluate the safety and efficacy of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Dispersion (NCD) administered orally with recombinant human monoclonal antibody against vascular endothelial growth factor (bevacizumab) administered intravenously, in patients with locally advanced or metastatic carcinoid tumors.

Details

Lead sponsor	CASI pharmaceuticals, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	31
Start date	2006-05
Completion	2009-12

Conditions

• Carcinoid Tumor

Interventions

• Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)

Primary outcomes

• To assess the safety of Panzem NCD administered orally in combination with intravenous infusion of bevacizumab by evaluation of the frequency and severity of treatment emergent adverse events — Approximately monthly
• To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors — Approximately every 8 weeks
• To determine the overall survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab — Approximately every 3 months

Countries

United States