NCT00878423

Study to Assess the Safety of Escalating Doses of AT13387 in Patients With Metastatic Solid Tumors

A Phase I Open-label Dose Escalation Study of AT13387 in Patients With Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AT13387/0001 is a dose-finding study of an experimental anticancer agent. In accordance with the protocol increasing doses of AT13387 are given to patients with advanced cancer who do not have alternative treatment options. The preferred dose of AT13387 will be identified according to the side effects experienced at different dose levels.

Detailed description

Increasing doses of AT13387 will be administered to groups of 3 to 6 patients at each dose level. The pharmacokinetic profile of AT13387 following a one hour intravenous infusion will be determined and the effect of AT13387 on predefined biomarkers in blood plasma and circulating white blood cells will be established. Patients will be closely monitored for the development of side effects which would preclude further dose escalation.

Conditions

• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	AT13387	Two dosing schedules will be evaluated; twice or once weekly dosing, on three weeks out of four. The starting dose for the once weekly schedule was 10mg/m2/dose, given as one hour intravenous (IV) infusions on Days 1, 4, 8, 11, 15 and 18 of a twenty-eight day cycle. The starting dose for the twice weekly schedule, given as one hour intravenous (IV) infusions on Days 1, 8 and 15 of a twenty-eight day cycle, will be 150mg/m2/dose
DRUG	AT13387	Intravenous infusion over one hour on days 1, 4, 8, 11, 15 and 18, every four weeks or intravenous infusion over one hour on days 1, 8 and 15, every four weeks . Treatment may be continued indefinitively in the presence of clinical benefit

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-05-01
• Completion: 2014-03-01
• First posted: 2009-04-09
• Last updated: 2024-08-02

Locations

4 sites across 1 country: United States