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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004349-34 | EudraCT Number |
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The study was stopped after the first Interim Analysis due to futility.
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The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival (OS) has been observed.
Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility.
The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganetespib and Docetaxel | Experimental | Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle. |
|
| Docetaxel | Active Comparator | Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel, 75 mg/m^2, was administered according to prevailing practice and Investigator decision, generally until disease progression, intolerability, or patient's withdrawal of consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival as of 19 October 2015 | Overall survival (OS) was measured from the date of randomization to the date of death from any cause. | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) as of 19 October 2015 | The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Biomarker Analyses | Exploratory biomarker analyses was to assess correlation between biomarkers and clinical outcome. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | up to 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates PC- NAHOA | Flagstaff | Arizona | 86001 | United States | ||
| Arizona Oncology Associates, PC- NAHOA |
1220 patients with advanced NSCLC of adenocarcinoma histology diagnosed ≥6 months prior to study entry were screened. 696 patients were randomized in a 1:1 ratio to two arms and stratified by:
209 sites screened at least one patient and 175 sites randomized at least one patient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ganetespib and Docetaxel | Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Ganetespib | Drug | Ganetespib, 150 mg/m^2, was administered with docetaxel. After docetaxel treatment ceased, participants whose disease has not progressed continued to receive ganetespib alone until disease progression, unacceptable toxicity, or patient's withdrawal of consent. |
|
|
| up to 36 months |
| Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | OS was measured from the date of randomization to the date of death from any cause. Elevated LDH includes values above the upper limit of normal. | up to 36 months |
| Objective Response Rate (ORR) as of 19 October 2015 | Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR). CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. | up to 36 months |
| Disease Control Rate (DCR) as of 19 October 2015 | Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR), a partial response (PR), or stable disease (SD). CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. For participants with a best response of SD, duration of SD must be for at least 6 weeks or 12 weeks. | up to 36 months |
| Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015 | Only participants who achieved a confirmed response (complete response (CR) or partial response (PR)) were included in the DOR analysis. CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. | up to 36 months |
| Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Elevated LDH includes values above the upper limit of normal. | up to 36 months |
| Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR). CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Elevated LDH includes values above the upper limit of normal. This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | up to 36 months |
| Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was a complete response (CR), a partial response (PR), or stable disease (SD). CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as <=30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. The duration of SD must be for at least 6 weeks or 12 weeks. Elevated LDH includes values above the upper limit of normal. This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | up to 36 months |
| Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015 | TNL was defined as time from the randomization date to the first day of radiological progression that included new metastatic lesions. Participants with no new metastatic lesions were censored at the date of the most recent radiological assessment. | up to 36 months |
| Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015 | Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth. | up to 36 months |
| Participants With Treatment-Emergent Adverse Events as of 23 December 2015 | Treatment-emergent adverse events (AEs) were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE (SAE) is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event. | up to 36 months |
| Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey | The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. An overall EQ-5D-3L index was calculated (see EuroQoL website, http://www.euroqol.org/eq-5d-products/eq-5d-3l.html), with an index of 1.0 representing full health and and "0" represents dead, with some health states being worse than dead (<"0"). This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial |
| Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test | The FACT-L contains 4 general subscales and a Lung Cancer Subscale (LCS). General subscales include: Physical Well-Being (PWB), Social/ Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The LCS assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, weight loss, and tightness in the chest). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Data were not summarized due to the early termination of the study due to futility. | Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial |
| Prescott Valley |
| Arizona |
| 86314 |
| United States |
| Northern Arizona Hematology & Oncology Associates | Sedona | Arizona | 86336 | United States |
| Arizona Clinical Research Center, Inc. | Tucson | Arizona | 85715 | United States |
| Pacific Cancer Medical Center, Inc | Anaheim | California | 92801 | United States |
| Comprehensive Blood & Cancer Center | Bakersfield | California | 93309 | United States |
| City of Hope Comprehensive Breast Cancer Center | Duarte | California | 91010 | United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Loma Linda University Cancer Center | Loma Linda | California | 92345 | United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| St. Joseph Hospital, Center for Cancer Prevention and Treatment | Orange | California | 92868 | United States |
| Cancer Care Associates Medical Group, Inc. | Redondo Beach | California | 90277 | United States |
| UC Davis Medical Center - UC Davis Comprehensive Cancer | Sacramento | California | 95817 | United States |
| Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | 93105-4230 | United States |
| City of Hope- South Pasadena | South Pasadena | California | 91030 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Eastern Connecticut Hematology Associates | Norwich | Connecticut | 06360 | United States |
| Medical Oncology Hematology Consultants, PA | Newark | Delaware | 19713 | United States |
| Lynn Cancer Institute Center for Hematology Oncology | Boca Raton | Florida | 33486 | United States |
| Halifax Health - Medical Center | Daytona Beach | Florida | 32114 | United States |
| University of Miami Health System Sylvester at Deerfield Beach | Deerfield Beach | Florida | 33442-7753 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Baptist Health Medical Group Oncology, LLC | Miami | Florida | 33176 | United States |
| University of South Florida - H. Lee Moffitt | Tampa | Florida | 33612 | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | United States |
| Emory University - Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Northwest Georgia Oncology Centers, PC | Marietta | Georgia | 30060 | United States |
| University Of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Cancer Care Specialists of Central Illinois, S.C. | Decatur | Illinois | 62526 | United States |
| Saint Anthony Medical Center | Rockford | Illinois | 61108 | United States |
| Fort Wayne Medical Oncology and Hematology Inc | Fort Wayne | Indiana | 46804 | United States |
| AAMC Oncology and Hematology | Annapolis | Maryland | 21401 | United States |
| The Center for Cancer and Blood Disorders (CCBD) - Bethesda | Bethesda | Maryland | 20817 | United States |
| The John R Marsh Cancer Center | Hagerstown | Maryland | 21742 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48909 | United States |
| St. Luke's Hospital Duluth | Duluth | Minnesota | 55805 | United States |
| Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | United States |
| St. Louis Cancer Care, LLP - North County | Bridgeton | Missouri | 63044 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| New Mexico Cancer Center | Albuquerque | New Mexico | 87109 | United States |
| North Shore Hematology Oncology Associates | East Setauket | New York | 11733 | United States |
| Clinical Research Alliance | Lake Success | New York | 11042 | United States |
| University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| New Hanover Regional Medical Center - Zimmer Cancer Center | Wilmington | North Carolina | 28401 | United States |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Tulsa Cancer Institute, PLLC | Tulsa | Oklahoma | 74146 | United States |
| Kaiser Permanente Northwest | Portland | Oregon | 97227 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Guthrie Medical Group, PC | Sayre | Pennsylvania | 18840 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Prairie Lakes Healthcare System | Watertown | South Dakota | 57201 | United States |
| Erlanger Institute for Clinical Research | Chattanooga | Tennessee | 37403 | United States |
| Associates In Oncology and Hematology | Chattanooga | Tennessee | 37421 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Texas Oncology-Arlington North | Arlington | Texas | 76012 | United States |
| Texas Oncology - Arlington South | Arlington | Texas | 76014 | United States |
| Texas Oncology, P.A. | Beaumont | Texas | 77702 | United States |
| Texas Oncology, PA | Dallas | Texas | 75246 | United States |
| Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | United States |
| Houston Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| Millennium Oncology | Houston | Texas | 77090 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| Cancer Care Centers Of South Texas | San Antonio | Texas | 78212 | United States |
| Cancer Care Centers Of South Texas | San Antonio | Texas | 78217 | United States |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78258 | United States |
| Texas Oncology - Sherman | Sherman | Texas | 75090 | United States |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | United States |
| Cancer Care Northwest | Spokane Valley | Washington | 99216 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| Mary Babb Cancer Center | Morgantown | West Virginia | 26506 | United States |
| Green Bay Oncology, Ltd. - St. Mary's Site | Green Bay | Wisconsin | 54303-3216 | United States |
| Green Bay Oncology | Green Bay | Wisconsin | 54307 | United States |
| Landesklinikum Krems | Krems | Lower Austria | 3500 | Austria |
| Bezirkskrankenhaus Kufstein [Onkologie] | Kufstein | Tyrol | A-6330 | Austria |
| Krankenhaus Der Barmherzigen Schwestern | Linz | Upper Austria | 4010 | Austria |
| Klinikum Wels-Grieskirchen | Wels | Upper Austria | A-4600 | Austria |
| Allgemeines Krankenhaus Linz | Linz | 4021 | Austria |
| Elisabeth Linz Hospital | Linz | 4021 | Austria |
| Otto Wagner Spital | Vienna | 1140 | Austria |
| Sozialmedizinisches Zentrum Baumgartner Höhe | Vienna | 1145 | Austria |
| AZ Sint-Maarten - Campus Leopoldstraat | Mechelen | Antwerpen | 2800 | Belgium |
| Clinique Saint-Pierre Ottignies | Ottignies | Brabant Wallon | 1340 | Belgium |
| Grand Hôpital de Charleroi - Site Notre-Dame | Charleroi | Hainaut | 6000 | Belgium |
| INDC Entité Jolimontoise - Polyclinique de Jolimont | Haine-Saint-Paul | Hainaut | 1700 | Belgium |
| CHU Dinant Godinne UCL Namur | Yvoir | Namur | 5533 | Belgium |
| Algemeen Stedelijk Ziekenhuis - Campus Aalst | Roeselaere | West-Vlaanderen | 8800 | Belgium |
| Cliniques Universitaire Saint-Luc | Brussels | 1200 | Belgium |
| CHR de la Citadelle - Site Citadelle | Liège | 4000 | Belgium |
| Clinical Centre Banja Luka | Banja Luka | Republika Srpska | 78000 | Bosnia and Herzegovina |
| University Clinical Center Tuzla | Tuzla | Tuzlanski kanton | 75000 | Bosnia and Herzegovina |
| Clinical Hospital Mostar | Mostar | 88108 | Bosnia and Herzegovina |
| Clinical Center University of Sarajevo, Clinic of Oncology | Sarajevo | 71000 | Bosnia and Herzegovina |
| University Clinical Centre Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| University Clinical Center Tuzla | Tuzla | 75000 | Bosnia and Herzegovina |
| Kantonalna bolnica Zenica | Zenica | 72000 | Bosnia and Herzegovina |
| Princess Margaret Hospital | Toronto | Ontario | MG5 2M9 | Canada |
| Mc Gill University-MUHC | Montreal | Quebec | H2W 1S6 | Canada |
| University Hospital Center Zagreb | Zagreb | City of Zagreb | 10 000 | Croatia |
| Opca bolnica Pula | Pula | Istria County | 52000 | Croatia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava - Poruba | 708 52 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Nemocnice Na Bulovce | Prague | 180 81 | Czechia |
| CHI des Alpes du Sud | Gap | Hautes-Alpes | 5000 | France |
| Centre D'Oncologie Du Pays Basque | Bayonne | Pyrénées-Atlantiques | 64100 | France |
| Centre Hosptalier De Villefranche-Sur-Saone | Villefranche-sur-Saône | Rhône | 69655 | France |
| Chi creteil | Créteil | Val-de-Marne | 94010 | France |
| Chu De Grenoble - Hopital Michallon | Grenoble | 38700 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Groupe Hospitalier Cochin | Paris | 75679 | France |
| Centre Hospitalier Universitaire de Rennes - Hopital d | Rennes | 35033 | France |
| Hôpital Charles Nicolle | Rouen | 76000 | France |
| CHRU de Strasbourg | Strasbourg | 67091 | France |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universiaetsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Schwarzwald-Baar-Klinikum | Villingen-Schwenningen | Baden-Wurttemberg | 78052 | Germany |
| Asklepios Fachklinik München-Gauting | Gauting | Bavaria | 82131 | Germany |
| Klinikum Bogenhausen | Munich | Bavaria | 81925 | Germany |
| Gesundheitszentrum Wetterau | Bad Nauheim | Hesse | 61231 | Germany |
| Johann Wolfgang Goethe University Clinic Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Johann Wolfgang Goethe University Clinic Frankfurt | Frankfurt am Main | Hesse | D-60590 | Germany |
| Klinikum Kassel | Kassel | Hesse | 34125 | Germany |
| Kliniken der Stadt Köln gGmbH | Cologne | North Rhine-Westphalia | 51109 | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | Saarland | 66421 | Germany |
| Universitätsklinikum Leipzig [Pneumologie] | Leipzig | Saxony | 04103 | Germany |
| Pneumologisches Forschungsinstitut an der Lungenclinic Gross | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| MVZ Äerzteforum Seestraße | Berlin | 13347 | Germany |
| Ev. Krankenhaus Bielefeld | Bielefeld | 33611 | Germany |
| Klinikum Frankfurt An Der Oder | Frankfurt (Oder) | 15236 | Germany |
| Practice Laack | Hamburg | 20251 | Germany |
| Unikl. Schleswig-Holstein - Lübeck | Lübeck | 23538 | Germany |
| J. Gutenberg Uni.Mainz | Mainz | 55101 | Germany |
| Medizinische Fakultät Mannheim Uni Heidelberg | Mannheim | 68167 | Germany |
| Gemeinschaftspraxis fuer Haematologie und Onkologie | Münster | 48149 | Germany |
| Klinikum Offenbach GmbH | Offenbach | 63069 | Germany |
| Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó | Deszk | Csongrád megye | 6772 | Hungary |
| Fejér Megyei Szent György Egyetemi Oktató Kórház | Székesfehérvár | Fejér | 8000 | Hungary |
| Országos Korányi TBC és Pulmonológiai Intézet | Budapest | Pest County | 1145 | Hungary |
| Semmelweis Egyetem | Budapest | 1125 | Hungary |
| Országos Korányi TBC és Pulmonológiai Intézet | Budapest | 1529 | Hungary |
| Békés Megyei Pándy Kálmán Kórház | Gyula | 5703 | Hungary |
| CRU Hungary Kft. | Miskolc | 3529 | Hungary |
| Irccs Irst | Meldola | Forli | 47014 | Italy |
| Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo | Viterbo | Lazio | 01100 | Italy |
| Azienda Ospedaliera San Gerardo | Monza | Lombardy | 20900 | Italy |
| CRO, IRCCS, Istituto Nazionale Tumori | Aviano | Pordenone | 33081 | Italy |
| Istituti Fisioterapici Ospitalieri Regina Elena | Roma | Roma | 00144 | Italy |
| Azienda Policlinico Umberto I | Rome | Roma | 00161 | Italy |
| Policlinico S.Orsola Malpighi, AOU di Bologna | Bologna | 40138 | Italy |
| AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can | Genova | 16132 | Italy |
| Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a | Milan | 20141 | Italy |
| Iov-Irccs | Padova | 35128 | Italy |
| Ospedale S.Maria della Misericordia, AO di Perugia, Universi | Perugia | 06156 | Italy |
| Ospedale Guglielmo da Saliceto, AUSL Piacenza | Piacenza | 29100 | Italy |
| Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona | Verona | 37134 | Italy |
| Ziekenhuis Assen | Assen | Drenthe | 9401 RK | Netherlands |
| Ziekenhuis St Jansdal | Harderwijk | Gelderland | 3844 DG | Netherlands |
| Gelre Ziekenhuis Zutphen | Zutphen | Gelderland | 7207 AE | Netherlands |
| academisch ziekenhuis Maastricht | Maastricht | Limburg | 6229 HX | Netherlands |
| Isala Klinieken Zwolle | Zwolle | Overijssel | 8025 AB | Netherlands |
| Sint Antoniusziekenhuis, location Utrecht | Utrecht | 3543 AZ | Netherlands |
| NZOZ Med Polonia | Poznan | Greater Poland Voivodeship | 60-693 | Poland |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii | Poznan | Greater Poland Voivodeship | 60569 | Poland |
| Medica Pro Familia Sp. z o.o. S.K.A. | Krakow | Lesser Poland Voivodeship | 31-002 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | Otwock | Masovian Voivodeship | 05-400 | Poland |
| Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Podlaskie Voivodeship | 15-540 | Poland |
| Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego | Łomża | Podlaskie Voivodeship | 18-400 | Poland |
| Szpital Wojewodzki Zespolony | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc | Olsztyn | 10-357 | Poland |
| Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach | Pilchowice | 44145 | Poland |
| Szpital Specjalistyczny | Prabuty | 82-550 | Poland |
| Wojewodzki Szpital Specjalistyczny im. M.Kopernika | Lodz | Łódź Voivodeship | 93-513 | Poland |
| Institutul Oncologic "Prof. Dr. Alex. Trestioreanu" | Bucharest | 022328 | Romania |
| Spitalul Clinic Coltea | Bucharest | 030171 | Romania |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | 050098 | Romania |
| Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca | Cluj-Napoca | 400015 | Romania |
| Medisprof | Cluj-Napoca | 400058 | Romania |
| Centrul de Oncologie Sf. Nectarie | Craiova | 200385 | Romania |
| Institutul Regional de Oncologie Iasi | Iași | 700483 | Romania |
| Oncomed | Timișoara | 300239 | Romania |
| Synta Pharmaceuticals Investigational Site | Chelyabinsk | 454087 | Russia |
| Synta Pharmaceuticals Investigational Site | Ivanovo | 153040 | Russia |
| Synta Pharmaceuticals Investigational Site | Izhevsk | 426067 | Russia |
| Synta Pharmaceuticals Investigational Site | Kemerovo | 650036 | Russia |
| Synta Pharmaceuticals Investigational Site | Krasnoyarsk | 660133 | Russia |
| Synta Pharmaceuticals Investigational Site | Kursk | 305035 | Russia |
| Synta Pharmaceuticals Investigational Site | Lipetsk | 398005 | Russia |
| Synta Pharmaceuticals Investigational Site | Moscow | 115478 | Russia |
| Synta Pharmaceuticals Investigational Site | Nizhny Novgorod | 603081 | Russia |
| Synta Pharmaceuticals Investigational Site | Novosibirsk | 630047 | Russia |
| Synta Pharmaceuticals Investigational Site | Omsk | 644013 | Russia |
| Synta Pharmaceuticals Investigational Site | Oryol | 302020 | Russia |
| Synta Pharmaceuticals Investigational Site | Rostov-on-Don | 344037 | Russia |
| Synta Pharmaceuticals Investigational Site | Saint Petersburg | 194017 | Russia |
| Synta Pharmaceuticals Investigational Site | Saint Petersburg | 197758 | Russia |
| Synta Pharmaceuticals Investigational Site | Saint Petersburg | 198255 | Russia |
| Synta Pharmaceuticals Investigational Site | Samara | 443031 | Russia |
| Synta Pharmaceuticals Investigational Site | Saransk | 430032 | Russia |
| Synta Pharmaceuticals Investigational Site | Sochi | 354057 | Russia |
| Synta Pharmaceuticals Investigational Site | Stavropol | 355047 | Russia |
| Synta Pharmaceuticals Investigational Site | Ufa | 450000 | Russia |
| Synta Pharmaceuticals Investigational Site | Ufa | 450054 | Russia |
| Synta Pharmaceuticals Investigational Site | Yekaterinburg | 620036 | Russia |
| Clinical Centre of Serbia | Belgrade | Belgrade | 11000 | Serbia |
| Clinical Centre Nis | Niš | Nišavski okrug | 18000 | Serbia |
| Institute for Oncology and Radiology of Serbia | Belgrade | 11000 | Serbia |
| Institute for pulmonary diseases of Vojvodine | Kamenitz | 21204 | Serbia |
| Clinical Center Kragujevac | Kragujevac | Šumadijski okrug | 34 000 | Serbia |
| Univerzitetna klinika za pljucne bolesti in alergijo Golnik | Golnik | 4204 | Slovenia |
| Onkoloski institut Ljubljana | Ljubljana | 1000 | Slovenia |
| Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera | A Coruña | A Coruña | 15006 | Spain |
| Synta Pharmaceuticals Investigational Site | Málaga | Andalusia | 29010 | Spain |
| H. Son Llàtzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital de Mataró, Consorci Sanitari del Maresme | Mataró | Barcelona | 08304 | Spain |
| Synta Pharmaceuticals Investigational Site | Santander | Cantabria | 39008 | Spain |
| Onkologikoa | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Synta Pharmaceuticals Investigational Site | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | 08916 | Spain |
| H.U. Vall d'Hebrón | Barcelona | 08035 | Spain |
| Synta Pharmaceuticals Investigational Site | Barcelona | 08036 | Spain |
| H.U. Reina Sofía | Córdoba | 14004 | Spain |
| Synta Pharmaceuticals Investigational Site | Girona | 17007 | Spain |
| Synta Pharmaceuticals Investigational Site | Madrid | 28033 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Synta Pharmaceuticals Investigational Site | Madrid | 28034 | Spain |
| F. Jiménez Diaz | Madrid | 28040 | Spain |
| Synta Pharmaceuticals Investigational Site | Madrid | 28041 | Spain |
| Hospital Madrid Norte Sanchinarro | Madrid | 28050 | Spain |
| Synta Pharmaceuticals Investigational Site | Madrid | 28223 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 460026 | Spain |
| Synta Pharmaceuticals Investigational Site | Cherkasy | 18009 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Chernivtsi | 58013 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Dnipro | 49102 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Donetsk | 83087 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Donetsk | 83092 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Ivano-Frankivsk | 76000 | Ukraine |
| Synta Pharmaceuticals Investigative Site | Kharkiv | 61070 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Khmelnytskyi | 29009 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Kirovohrad | 25011 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Kryvyi Rih | 50048 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Kyiv | 03115 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Makiivka | 86120 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Poltava | 36011 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Simferopol | 95023 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Sumy | 40022 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Uzhhorod | 88014 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Vinnytsia | 21021 | Ukraine |
| Synta Pharmaceuticals Investigational Site | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Shrewsbury | Shropshire | SY3 8XQ | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Swindon | Wiltshire | SN3 6BB | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Cardiff | CF14 2TL | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Edinburgh | EH4 2XU | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Leicester | LEI 5WW | United Kingdom |
| Synta Pharmaceuticals Investigational Site | London | SE1 9RT | United Kingdom |
| Synta Pharmaceuticals Investigational Site | London | SW3 6JJ | United Kingdom |
| Synta Pharmaceuticals Investigational Site | London | W6 8RF | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Nottingham | NG5 1PB | United Kingdom |
| Synta Pharmaceuticals Investigational Site | Southampton | SO16 6YD | United Kingdom |
| Docetaxel |
Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion. |
| Safety Population as of 23 Dec 2015 |
|
| Randomized as of 19 October 2015 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants as of 23 December 2015
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ganetespib and Docetaxel | Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle. |
| BG001 | Docetaxel | Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Geographic region | Number | participants |
| ||||||||||||||||
| Smoking History | Number | participants |
| ||||||||||||||||
| Time from Advanced NCSLC Diagnosis to Consent | NCSLC = non-small-cell lung cancer | Mean | Standard Deviation | months |
| ||||||||||||||
| Stage at Initial Diagnosis | Disease stage described using American Joint Committee on Cancer (AJCC). Stages ranged from I (cancer was small and had not spread to the lymph nodes) to IV (cancer spread throughout the body). Stage III (cancer had spread to nearby tissue or lymph nodes) was further differentiated based on regional lymph nodes: Stage IIIA (spread to nearby lymph nodes) and Stage IIIB (spread to distance lymph nodes). | Number | participants |
| |||||||||||||||
| ECOG at Study Entry | Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants' disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. | Number | participants |
| |||||||||||||||
| Lactate Dehydrogenase (LDH) at Study Entry | Number | participants |
| ||||||||||||||||
| Brain Metastasis | Number | participants |
| ||||||||||||||||
| Bone Metastasis | Number | participants |
| ||||||||||||||||
| Intra-Thoracic Metastasis only | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival as of 19 October 2015 | Overall survival (OS) was measured from the date of randomization to the date of death from any cause. | Randomized participants | Posted | Median | 95% Confidence Interval | months | up to 36 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) as of 19 October 2015 | The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Randomized participants | Posted | Median | 95% Confidence Interval | months | up to 36 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | OS was measured from the date of randomization to the date of death from any cause. Elevated LDH includes values above the upper limit of normal. | Randomized participants with elevated LDH at screening | Posted | Median | 95% Confidence Interval | months | up to 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) as of 19 October 2015 | Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR). CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. | Randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | up to 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) as of 19 October 2015 | Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR), a partial response (PR), or stable disease (SD). CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. For participants with a best response of SD, duration of SD must be for at least 6 weeks or 12 weeks. | Randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | up to 36 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015 | Only participants who achieved a confirmed response (complete response (CR) or partial response (PR)) were included in the DOR analysis. CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. | Randomized participants who had a confirmed response | Posted | Median | 95% Confidence Interval | months | up to 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Elevated LDH includes values above the upper limit of normal. | Randomized participants who had an elevated screening LDH | Posted | Median | 95% Confidence Interval | months | up to 36 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR). CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Elevated LDH includes values above the upper limit of normal. This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | Posted | up to 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was a complete response (CR), a partial response (PR), or stable disease (SD). CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as <=30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. The duration of SD must be for at least 6 weeks or 12 weeks. Elevated LDH includes values above the upper limit of normal. This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | Posted | up to 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015 | TNL was defined as time from the randomization date to the first day of radiological progression that included new metastatic lesions. Participants with no new metastatic lesions were censored at the date of the most recent radiological assessment. | Randomized participants | Posted | Median | 95% Confidence Interval | months | up to 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015 | Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth. | Randomized participants | Posted | Number | percentage of participants | up to 36 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Biomarker Analyses | Exploratory biomarker analyses was to assess correlation between biomarkers and clinical outcome. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | Randomized | Posted | up to 36 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Treatment-Emergent Adverse Events as of 23 December 2015 | Treatment-emergent adverse events (AEs) were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE (SAE) is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event. | Safety population | Posted | Number | participants | up to 36 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey | The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. An overall EQ-5D-3L index was calculated (see EuroQoL website, http://www.euroqol.org/eq-5d-products/eq-5d-3l.html), with an index of 1.0 representing full health and and "0" represents dead, with some health states being worse than dead (<"0"). This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | Randomized participants. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis. | Posted | Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test | The FACT-L contains 4 general subscales and a Lung Cancer Subscale (LCS). General subscales include: Physical Well-Being (PWB), Social/ Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The LCS assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, weight loss, and tightness in the chest). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Data were not summarized due to the early termination of the study due to futility. | Randomized participants | Posted | Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial |
|
up to 36 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Docetaxel | Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion. | 107 | 342 | 293 | 342 | ||
| EG001 | Ganetespib and Docetaxel | Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle. | 139 | 338 | 308 | 338 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mesenteric artery thrombosis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (18.0) | Systematic Assessment | When an SAE of death is received, the site is queried to request additional information. If the site is not able to determine a specific adverse event, they report 'death' as the event. |
|
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Strangulated hernia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Immunodeficiency | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Hypovolaemia | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cancer surgery | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
Sponsor has the right, 60 days before submission for publication, to review disclosures and require deletion of its confidential information, excluding the study results. Public disclosure shall be delayed for up to 60 additional days in order for the Sponsor to file a patent application, if needed. Single center publications will be postponed until after disclosure of pooled data (all sites), or, for a period of 18 months from study completion/termination at all participating sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| President, Chief Executive Officer | Synta Pharmaceuticals | 781-541-7261 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C533237 | STA 9090 |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Western Europe |
|
| Rest of World |
|
| Ever Smoked |
|
| Unknown |
|
| IIIA |
|
| IIIB |
|
| IV |
|
| Unknown |
|
| 1 = Restrictive but Ambulatory |
|
| 2 = Ambulatory unable to Work |
|
| 3 = Limited Self-Care |
|
| 4 = Completely Disabled |
|
| Elevated |
|
| No |
|
| No |
|
| No |
|
Futility analysis for the first Interim Analysis which had a database cutoff of 19 October 2015. For the first interim analysis, if the lower limit of the 2-sided 99.5% confidence interval (CI) for the Hazard Ratio was greater than 0.75, then the study could be stopped for futility, based on Data Monitoring Committee recommendation. Hazard ratio and 99.5% CI were calculated using the stratified Cox Proportional Hazards model (strata: screening LDH, screening ECOG and geographic region). |
| Hazard Ratio (HR) |
| 1.111 |
| 2-Sided |
| 99.5 |
| 0.821 |
| 1.503 |
| No |
| Superiority or Other |
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
| OG001 | Docetaxel | Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion. |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|