Non Small Cell Lung Cancer Clinical Trial
Official title:
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
Verified date | May 2014 |
Source | Infinity Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 226 |
Est. completion date | April 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hungary | Országos Korányi TBC és Pulmonológiai Intézet | Budapest | |
Hungary | Országos Korányi TBC és Pulmonológiai Intézet | Budapest | |
Hungary | Pándy Kálmán Megyei Kórház | Gyula | Bekes |
Hungary | Mátrai Gyógyintézet | Mátraháza | Heves |
Hungary | Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza | Sopron | Gyor-moson-sopron |
Hungary | Zala Megyei Kórház | Zalaegerszeg | Zala |
Korea, Republic of | Dong-A University Medical Center | Busan | |
Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do |
Korea, Republic of | Inha University Hospital | Jung Gu | Incheon |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Severance Hospital,Yonsei University Health System | Seoul | |
Romania | 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 | Spitalul Clinic Judetean de Urgenta Sibiu | Sibiu | |
Russian Federation | State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary" | Chelaybinsk | |
Russian Federation | 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 | City Oncology Hospital # 62 | Moscow Region | Moscow |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Tri-Service General Hospital | Taipei | |
United States | Ann Arbor Hematology Oncology Associates | Ann Arbor | Michigan |
United States | Texas Oncology-Arlington South | Arlington | Texas |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Central Indiana Cancer Centers | Carmel | Indiana |
United States | Ironwood Cancer and Research Center | Chandler | Arizona |
United States | Charleston Hematology Oncology Associates, PA | Charleston | South Carolina |
United States | Blumenthal Cancer Center | Charlotte | North Carolina |
United States | Chattanooga Oncology and Hematology Associates, PC | Chattanooga | Tennessee |
United States | Oncology Hematology Care, Inc. | Cincinnati | Ohio |
United States | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | Puget Sound Cancer Centers | Edmonds | Washington |
United States | Willamette Valley Cancer Institute and Research Center | Eugene | Oregon |
United States | Florida Cancer Specialists | Fort Myers | Florida |
United States | Indiana University | Indianapolis | Indiana |
United States | Broome Oncology, LLC | Johnson City | New York |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
United States | Owsley Brown Frazier Cancer Center-Louisville Downtown | Louisville | Kentucky |
United States | Signal Point Clinical Research Center, LLC | Middletown | Ohio |
United States | Indiana University Health Ball Memorial Hospital | Muncie | Indiana |
United States | Community Hospital | Munster | Indiana |
United States | Sarah Cannon Cancer Center | Nashville | Tennessee |
United States | Floyd Memorial Cancer Center of Indiana | New Albany | Indiana |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | Tulane University | New Orleans | Louisiana |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | University of California Irvine Medical Center | Orange | California |
United States | PMK Medical Group, Inc. | Oxnard | California |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga | California |
United States | Virginia Cancer Institute | Richmond | Virginia |
United States | University of Rochester | Rochester | New York |
United States | Florida Cancer Specialists and Research Institute | Saint Petersburg | Florida |
United States | University of Utah Hospital and Clinics | Salt Lake City | Utah |
United States | Cancer Centers of the Carolinas | Seneca | South Carolina |
United States | Arizona Oncology Associates | Tucson | Arizona |
United States | Texas Oncology-Tyler | Tyler | Texas |
United States | American Institute of Research | Whittier | California |
United States | Piedmont Hematology Oncology Associates, PLLC | Winston Salem | North Carolina |
United States | Piedmont Hematology Oncology Associates, PLLC | Winston-Salem | North Carolina |
United States | Metro Health Cancer Center | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
Infinity Pharmaceuticals, Inc. |
United States, Hungary, Korea, Republic of, Romania, Russian Federation, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Progression Free Survival | 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 | Up to three years from last patient study visit | No |
Secondary | Overall Response Rate | To determine partial response or complete response occurring at any point post-treatment | Up to three years from last patient study visit | No |
Secondary | Time to Progression | 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 | Up to three years from last patient study visit | No |
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