A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Drug: IPI 504 plus Docetaxel
- Registration Number
- NCT01362400
- Lead Sponsor
- Infinity Pharmaceuticals, Inc.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 226
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARM 1: IPI 504 + Docetaxel IPI 504 plus Docetaxel Drug: IPI-504 plus Docetaxel Placebo + Docetaxel Placebo plus Docetaxel Placebo plus Docetaxel
- Primary Outcome Measures
Name Time Method Overall Survival Up to three years from last patient study visit To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
- Secondary Outcome Measures
Name Time Method Progression Free Survival Up to three years from last patient study visit To determine the progression free survival rate from randomization to progression or death whichever occurs first, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel
Overall Response Rate Up to three years from last patient study visit To determine partial response or complete response occurring at any point post-treatment
Time to Progression Up to three years from last patient study visit To identify the amount of time from randomization to progression, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel
Trial Locations
- Locations (64)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Chattanooga Oncology and Hematology Associates, PC
🇺🇸Chattanooga, Tennessee, United States
Texas Oncology-Arlington South
🇺🇸Arlington, Texas, United States
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Ironwood Cancer and Research Center
🇺🇸Chandler, Arizona, United States
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Spitalul Clinic Judetean de Urgenta Sibiu
🇷🇴Sibiu, Romania
City Oncology Hospital # 62
🇷🇺Moscow Region, Moscow, Russian Federation
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Országos Korányi TBC és Pulmonológiai Intézet
🇭🇺Budapest, Hungary
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
🇷🇺Chelaybinsk, Russian Federation
China Medical University Hospital
🇨🇳Taichung, Taiwan
Florida Cancer Specialists and Research Institute
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Broome Oncology, LLC
🇺🇸Johnson City, New York, 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
Indiana University Health Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Floyd Memorial Cancer Center of Indiana
🇺🇸New Albany, Indiana, United States
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Inha University Hospital
🇰🇷Jung Gu, Incheon, Korea, Republic of
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Utah Hospital and Clinics
🇺🇸Salt Lake City, Utah, United States
American Institute of Research
🇺🇸Whittier, California, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Community Hospital
🇺🇸Munster, Indiana, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Cancer Centers of the Carolinas
🇺🇸Seneca, South Carolina, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Puget Sound Cancer Centers
🇺🇸Edmonds, Washington, United States
Texas Oncology-Tyler
🇺🇸Tyler, Texas, United States
Pándy Kálmán Megyei Kórház
🇭🇺Gyula, Bekes, Hungary
Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza
🇭🇺Sopron, Gyor-moson-sopron, Hungary
Mátrai Gyógyintézet
🇭🇺Mátraháza, Heves, Hungary
Zala Megyei Kórház
🇭🇺Zalaegerszeg, Zala, Hungary
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeollanam-do, Korea, Republic of
Severance Hospital,Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Dong-A University Medical Center
🇰🇷Busan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Spitalul de Urgenta "Constantin Opris"
🇷🇴Baia Mare, Maramures, Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta"
🇷🇴Cluj-Napoca, Cluj, Romania
Spitalul Municipal Ploiesti
🇷🇴Ploiesti, Prahova, Romania
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
🇷🇺Moscow, Russian Federation
Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD"
🇷🇺Moscow, Russian Federation
Signal Point Clinical Research Center, LLC
🇺🇸Middletown, Ohio, United States
Oncology Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
Central Indiana Cancer Centers
🇺🇸Carmel, Indiana, United States
University of Rochester
🇺🇸Rochester, New York, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Blumenthal Cancer Center
🇺🇸Charlotte, North Carolina, United States
Metro Health Cancer Center
🇺🇸Wyoming, Michigan, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Owsley Brown Frazier Cancer Center-Louisville Downtown
🇺🇸Louisville, Kentucky, United States
Ann Arbor Hematology Oncology Associates
🇺🇸Ann Arbor, Michigan, United States
Charleston Hematology Oncology Associates, PA
🇺🇸Charleston, South Carolina, United States
Piedmont Hematology Oncology Associates, PLLC
🇺🇸Winston-Salem, North Carolina, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States