Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)

Infinity Pharmaceuticals, Inc.88 enrolled

Overview

The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also evaluate the anti-tumor activity of IPI-504.

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 clinical trial will study the effects of IPI-504 in a molecularly defined sub-group of patients who carry client proteins found in non-small cell lung cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

IPI-504DRUG

IV Hsp90 inhibitor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC * Measurable disease by RECIST criteria. Exclusion Criteria: * Treatment for NSCLC with any approved or investigational product within 2 weeks of the start of IPI-504 treatment for any small molecule therapy; within 4 weeks of the start of IPI-504 treatment for any biologic or any conventional chemotherapy. * Inadequate hematologic or renal or hepatic function * Previous treatment with 17-AAG, DMAG or other known Hsp90 inhibitor.

Locations (11)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Mount Sinai Comprehensive Cancer Center

Miami, Florida, United States

Outcomes

Primary Outcomes

Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria

Time frame: Every 6 weeks

Data from ClinicalTrials.gov

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