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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 88
- Locations
- 11
- Primary Endpoint
- Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
Secondary Outcomes
No secondary outcomes reported