Clinical trial NCT00431015: Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Keywords: Lung Cancer
Cancer of the lung
Non-small cell lung cancer
Lead sponsor: Infinity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-02-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria
timeFrame: Every 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: New Haven
country: United States
facility: Yale Comprehensive Cancer Center
state: Connecticut
city: Miami
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Centers - Medical City
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Centers - Baylor
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Massachusetts General Hospital
name: Lecia Sequist, MD
role: PRINCIPAL_INVESTIGATOR
References: