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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Every 6 weeks

Safety Issue:

No

Principal Investigator

Lecia Sequist, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

IPI-504-03

NCT ID:

NCT00431015

Start Date:

January 2007

Completion Date:

December 2011

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Cancer of the lung
  • Non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pericardial Effusion

Name

Location
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cedars-Sinai Medical Center Los Angeles, California  90048
Hackensack University Medical Center Hackensack, New Jersey  07601
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Seattle Cancer Care Alliance Seattle, Washington  98109
Medical College of Georgia Augusta, Georgia  30912
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Mary Crowley Cancer Research Centers - Baylor Dallas, Texas  75246
Mary Crowley Cancer Research Centers - Medical City Dallas, Texas  75201