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A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

Thank you

Trial Information

A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with
previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to
compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at
least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology
reviewer to confirm pathology that is documented at baseline; this review need not occur in
advance of randomization.

Inclusion Criteria:

- Patients must be ≥18 years of age

- Voluntarily signed an informed consent

- Confirmed NSCLC and Stage IIIB or IV disease.

- At least a ≥15 pack year smoking history and must have been an active smoker within
20 years of diagnosis.

- Must have archival NSCLC tissue available to provide for analysis or have a lesion
that is accessible for biopsy

- Must have experienced disease progression during or after receiving at least 1 prior
platinum-containing chemotherapy regimen.

- Must have received no more than 2 prior chemotherapy regimens

- Measurable disease by RECIST 1.1 criteria.

- ECOG performance status of 0 or 1 (Refer to scale in Appendix 1).

- Women of child-bearing potential (WCBP), all sexually active male patients, and
partners of patients must agree to use adequate methods of birth control.

Exclusion Criteria:

- Prior docetaxel, IPI-504 or other Hsp90 inhibitor treatment

- Known hypersensitivity to drugs formulated with polysorbate-80.

- Not recovered from any toxicities related to prior treatment

- Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer

- Inadequate hematologic function

- Inadequate hepatic function

- Inadequate renal function

- Symptomatic keratitis or keratoconjunctivitis.

- Uncontrolled systemic fungal, bacterial, viral or other infection

- Patients with clinically active brain metastases

- Patients with clinically stable brain metastases (previously treated or untreated)
are eligible.

- Sinus bradycardia (resting heart rate <50 bpm).

- Significant cardiac disease

- Previous or current malignancies at other sites within the last 2 years

- Prior hepatic resections or hepatic-directed therapy

- Known HIV-positive patients receiving combination antiretroviral therapy.

- Women who are pregnant or lactating.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel

Outcome Time Frame:

Up to three years from last patient study visit

Safety Issue:


Principal Investigator

Tess Schmalbach, MD

Investigator Role:

Study Director

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:

IPI 504-14



Start Date:

May 2011

Completion Date:

December 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730
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Community Hospital Munster, Indiana  46321
University of Rochester Rochester, New York  14642
Arizona Oncology Associates Tucson, Arizona  85712-2254
Providence Portland Medical Center Portland, Oregon  97213-3635
Sarah Cannon Cancer Center Nashville, Tennessee  37203
Oncology Hematology Care, Inc. Cincinnati, Ohio  45219
Blumenthal Cancer Center Charlotte, North Carolina  28203
Virginia Cancer Institute Richmond, Virginia  23230
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Broome Oncology, LLC Johnson City, New York  13790
Indiana University Indianapolis, Indiana  46202
Karmanos Cancer Institute Detroit, Michigan  48201
Piedmont Hematology Oncology Associates, PLLC Winston-Salem, North Carolina  
University of California Irvine Medical Center Orange, California  92668
Puget Sound Cancer Centers Edmonds, Washington  98026
Southeast Nebraska Cancer Center Lincoln, Nebraska  68510
Tulane University New Orleans, Louisiana  70112-2699
Charleston Hematology Oncology Associates, PA Charleston, South Carolina  29403
Signal Point Clinical Research Center, LLC Middletown, Ohio  45042
Willamette Valley Cancer Institute and Research Center Springfield, Oregon  97477
Texas Oncology-Tyler Tyler, Texas  75702
Chattanooga Oncology and Hematology Associates, PC Chattanooga, Tennessee  37404
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas, Texas  75246
Ironwood Cancer and Research Center Chandler, Arizona  85224
American Institute of Research Whittier, California  90603
Floyd Memorial Cancer Center of Indiana New Albany, Indiana  47150
PMK Medical Group, Inc. Oxnard, California  93030
Florida Cancer Specialists and Research Institute Saint Petersburg, Florida  33705
Indiana University Health Ball Memorial Hospital Muncie, Indiana  47303
Owsley Brown Frazier Cancer Center-Louisville Downtown Louisville, Kentucky  40215
Ann Arbor Hematology Oncology Associates Ann Arbor, Michigan  48158
Metro Health Cancer Center Wyoming, Michigan  49519
Texas Oncology-Arlington South Arlington, Texas  76014
University of Utah Hospital and Clinics Salt Lake City, Utah  84112