Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS)

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of the study are:

• Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies

• Recommend a dose for subsequent studies of IPI-504

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Pathologically confirmed diagnosis of GIST or STS

• Failed prior therapies

• ECOG performance status of 0-2

• Ability to adhere to the study visit schedule and all protocol requirements

Exclusion Criteria:

• Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor

• Participation in any investigational drug study or treatment with any other kinase inhibitor therapy within 2 weeks preceding start of treatment

• Concurrent radiation therapy is not permitted

• Concurrent treatment with any agent that alters CYP3A activity

• Concurrent treatment with any agent that may prolong the QTc interval

• Myocardial infarction or active ischemic heart disease within 6 months

• History of arrhythmia

• Baseline QTc >450

• Grade 3 or greater peripheral neuropathy

• Renal insufficiency, serum creatinine >1.5 x ULN

• Platelets < 100,000 mm3

• AST and / or ALT > 2.5 x ULN

• ANC <1,500 cells/mm3

• Alkaline phosphatase > 2.5 x ULN

• Amylase and lipase > 1.5 x ULN

• Hemoglobin < 9.0 g/dL