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

Completed · Phase 1

Conditions studied: Gastrointestinal Stromal Tumors, Soft Tissue Sarcomas

In brief

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

Key facts

Study ID

NCT00276302

Run by

Infinity Pharmaceuticals, Inc.

People needed

63

Starts

2005-12-01

Expected to finish

2010-11-01

Last updated by the study team

2011-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Premiere Oncology — Scottsdale, Arizona, United States
• Premiere Oncology — Santa Monica, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Hosptials — Ann Arbor, Michigan, United States
• Mount Sinai Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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