Spots Global Cancer Trial Database for Study of EC0489 for the Treatment of Refractory or Metastatic Tumors

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Trial Identification

Brief Title: Study of EC0489 for the Treatment of Refractory or Metastatic Tumors

Official Title: A Phase I Study of EC0489 Administered Weeks 1 and 3 of a 4-Week Cycle

Study ID: NCT00852189

Conditions

Cancer

Interventions

EC0489, Injection

EC20

EC0489, Injection

Study Description

Brief Summary: This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Detailed Description: This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B. Both Parts are open to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 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 EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.