A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Non Small Cell Lung Cancer

In brief

The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer

Key facts

Study ID

NCT01362400

Run by

Infinity Pharmaceuticals, Inc.

People needed

226

Starts

2011-05-01

Expected to finish

2014-04-01

Last updated by the study team

2014-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Oncology Associates — Tucson, Arizona, United States
• University of California Irvine Medical Center — Orange, California, United States
• PMK Medical Group, Inc. — Oxnard, California, United States
• Wilshire Oncology Medical Group, Inc. — Rancho Cucamonga, California, United States
• American Institute of Research — Whittier, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists and Research Institute — St. Petersburg, Florida, United States
• Central Indiana Cancer Centers — Carmel, Indiana, United States
• Indiana University — Indianapolis, Indiana, United States
• Indiana University Health Ball Memorial Hospital — Muncie, Indiana, United States
• Community Hospital — Munster, Indiana, United States
• Floyd Memorial Cancer Center of Indiana — New Albany, Indiana, United States
• Owsley Brown Frazier Cancer Center-Louisville Downtown — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Ann Arbor Hematology Oncology Associates — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Sparrow Regional Cancer Center — Lansing, Michigan, United States
• Metro Health Cancer Center — Wyoming, Michigan, United States
• Southeast Nebraska Cancer Center — Lincoln, Nebraska, United States
• Broome Oncology, LLC — Johnson City, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Ironwood Cancer and Research Center — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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