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

A Phase I/II Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and / or Refractory Stage IIIb (With Malignant Pleural or Pericardial Effusion), or Stage IV NSCLC Patients

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00431015

Enrollment

Registered

2007-02-02

Start date

2007-01-31

Completion date

2011-12-31

Last updated

2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung Cancer, Cancer of the lung, Non-small cell lung cancer

Brief summary

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.

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 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.

Interventions

DRUGIPI-504

IV Hsp90 inhibitor

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria	Every 6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026