A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
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
1 other identifier
interventional
226
6 countries
65
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Typical duration for phase_2
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 19, 2014
May 1, 2014
2.8 years
May 26, 2011
May 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
Up to three years from last patient study visit
Secondary Outcomes (3)
Progression Free Survival
Up to three years from last patient study visit
Overall Response Rate
Up to three years from last patient study visit
Time to Progression
Up to three years from last patient study visit
Study Arms (2)
ARM 1: IPI 504 + Docetaxel
ACTIVE COMPARATORDrug: IPI-504 plus Docetaxel
Placebo + Docetaxel
PLACEBO COMPARATORPlacebo plus Docetaxel
Interventions
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)
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)
Eligibility Criteria
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Ironwood Cancer and Research Center
Chandler, Arizona, 85224, United States
Arizona Oncology Associates
Tucson, Arizona, 85715-4900, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
PMK Medical Group, Inc.
Oxnard, California, 93030, United States
Wilshire Oncology Medical Group, Inc.
Rancho Cucamonga, California, 91730, United States
American Institute of Research
Whittier, California, 90603, United States
Yale Cancer Center
New Haven, Connecticut, 06519, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705, United States
Central Indiana Cancer Centers
Carmel, Indiana, 46032, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Community Hospital
Munster, Indiana, 46321, United States
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, 47150, United States
Owsley Brown Frazier Cancer Center-Louisville Downtown
Louisville, Kentucky, 40215, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Ann Arbor Hematology Oncology Associates
Ann Arbor, Michigan, 48158, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912, United States
Metro Health Cancer Center
Wyoming, Michigan, 49519, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
Broome Oncology, LLC
Johnson City, New York, 13790, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 14642, United States
University of Rochester
Rochester, New York, 14642, United States
Blumenthal Cancer Center
Charlotte, North Carolina, 28203, United States
Piedmont Hematology Oncology Associates, PLLC
Winston-Salem, North Carolina, 27103, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, 29672, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, 37404, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Texas Oncology-Arlington South
Arlington, Texas, 76014, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84112, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Puget Sound Cancer Centers
Edmonds, Washington, 98026, United States
Pándy Kálmán Megyei Kórház
Gyula, Bekes County, 5703, Hungary
Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza
Sopron, Győr-Moson-Sopron, 9400, Hungary
Mátrai Gyógyintézet
Mátraháza, Heves County, 3233, Hungary
Zala Megyei Kórház
Zalaegerszeg, Zala County, 8900, Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, 1121, Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, 1529, Hungary
Institutul Oncologic "Prof. Dr. I. Chiricuta"
Cluj-Napoca, Cluj, 400015, Romania
Spitalul de Urgenta "Constantin Opris"
Baia Mare, Maramureş, 430031, Romania
Spitalul Municipal Ploiesti
Ploieşti, Prahova, 100337, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Sibiu County, 500245, Romania
City Oncology Hospital # 62
Moscow Region, Moscow, 143423, Russia
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
Chelaybinsk, 454087, Russia
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
Moscow, 115478, Russia
Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD"
Moscow, 129128, Russia
National Cancer Center
Goyang-si, Gyeonggi-do, 411-769, South Korea
Inha University Hospital
Jung Gu, Incheon, 400-711, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 519-763, South Korea
Dong-A University Medical Center
Busan, 602-715, South Korea
Severance Hospital,Yonsei University Health System
Seoul, 120-752, South Korea
Asan Medical Center
Seoul, 138-876, South Korea
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tess Schmalbach, MD
Infinity Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 30, 2011
Study Start
May 1, 2011
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
May 19, 2014
Record last verified: 2014-05