NCT00441870

Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Endocyte · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Detailed description

This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)	Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)
DRUG	99mTC-EC20 (Folic acid-technetium 99m conjugate)	20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-03-01
• Last updated: 2012-03-09

Locations

3 sites across 1 country: United States