A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
NCT ID: NCT01362400
Last Updated: 2014-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2011-05-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ARM 1: IPI 504 + Docetaxel
Drug: IPI-504 plus Docetaxel
IPI 504 plus Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle
75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
Placebo + Docetaxel
Placebo plus Docetaxel
Placebo plus Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle
75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
Interventions
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IPI 504 plus Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle
75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
Placebo plus Docetaxel
450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle
75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Infinity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tess Schmalbach, MD
Role: STUDY_DIRECTOR
Infinity Pharmaceuticals, Inc.
Locations
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Ironwood Cancer and Research Center
Chandler, Arizona, United States
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
Blumenthal Cancer Center
Charlotte, North Carolina, United States
Piedmont Hematology Oncology Associates, PLLC
Winston-Salem, North Carolina, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Texas Oncology-Arlington South
Arlington, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Puget Sound Cancer Centers
Edmonds, Washington, United States
Pándy Kálmán Megyei Kórház
Gyula, Bekes County, Hungary
Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza
Sopron, Győr-Moson-Sopron, Hungary
Mátrai Gyógyintézet
Mátraháza, Heves County, Hungary
Zala Megyei Kórház
Zalaegerszeg, Zala County, Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, , Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, , Hungary
Institutul Oncologic "Prof. Dr. I. Chiricuta"
Cluj-Napoca, Cluj, Romania
Spitalul de Urgenta "Constantin Opris"
Baia Mare, Maramureş, Romania
Spitalul Municipal Ploiesti
Ploieşti, Prahova, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Sibiu County, Romania
City Oncology Hospital # 62
Moscow Region, Moscow, Russia
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
Chelaybinsk, , Russia
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
Moscow, , Russia
Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD"
Moscow, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Inha University Hospital
Jung Gu, Incheon, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Dong-A University Medical Center
Busan, , South Korea
Severance Hospital,Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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IPI 504-14
Identifier Type: -
Identifier Source: org_study_id
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