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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1: IPI 504 + Docetaxel | Active Comparator | Drug: IPI-504 plus Docetaxel |
|
| Placebo + Docetaxel | Placebo Comparator | Placebo plus Docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPI 504 plus Docetaxel | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tess Schmalbach, MD | Infinity Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer and Research Center | Chandler | Arizona | 85224 | United States | ||
| Arizona Oncology Associates |
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|
|
| Placebo plus Docetaxel | Drug | 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) |
|
|
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D018287 | Carcinoma, Large Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| C112765 | tanespimycin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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