NCT00606814

Phase I Study of IPI-504 and Docetaxel in Patients With Advanced Solid Tumors

A Phase I Study of IPI-504 and Docetaxel in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Infinity Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase I clinical trial of IPI-504 in combination with docetaxel (Taxotere).The purposes of the study are to determine: * the safety profile, * the highest dose of IPI-504 that can be given with docetaxel without causing severe side effects, and * to recommend a Phase II dose of the combination in patients with solid tumors.

Detailed description

IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90), an emerging and recently identified target for cancer therapy. Hsp90 is a protein chaperone that plays a central role in maintaining the proper folding, function and viability of various "client proteins". Many of the client proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. This is a multi-center, open-label, dose escalating study in which patients will be treated with a fixed dose of docetaxel followed by IPI-504 following one of three dosing schedules. Once an MTD has been defined, up to 20 additional patients with non-small cell lung cancer (NSCLC) will be enrolled.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	IPI-504, docetaxel	1. IPI-504 administered IV at a dose of 300mg/m2 2. Docetaxel at a fixed dose of 75 mg/m2 for every 3 weeks dose administration or 36 mg/m2 for weekly administration

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-05-01
• Completion: 2011-12-01
• First posted: 2008-02-05
• Last updated: 2012-03-06

Locations

8 sites across 1 country: United States