A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (Galaxy 2)

This study has been terminated.
(The study was stopped after the first Interim Analysis due to futility.)
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01798485
First received: February 4, 2013
Last updated: May 26, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Non-Small-Cell Lung Adenocarcinoma
Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Stage IV
Non-small Cell Lung Cancer Metastatic
Drug: Docetaxel
Drug: Ganetespib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • Overall Survival as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    Overall survival (OS) was measured from the date of randomization to the date of death from any cause.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

    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.


  • Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    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.

  • Objective Response Rate (ORR) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

    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.


  • Disease Control Rate (DCR) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

    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.


  • Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

    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.


  • Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

    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.


  • Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

    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.


  • Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

    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.


  • Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.

  • Participants With Treatment-Emergent Adverse Events as of 23 December 2015 [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]

    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.


  • Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey [ Time Frame: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial ] [ Designated as safety issue: No ]

    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.


  • Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test [ Time Frame: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Exploratory Biomarker Analyses [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 696
Study Start Date: April 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Docetaxel
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.
Other Names:
  • Taxotere
  • Docecad
Drug: Ganetespib
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.
Other Name: STA-9090
Active Comparator: Docetaxel
Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Drug: Docetaxel
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.
Other Names:
  • Taxotere
  • Docecad

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
  • Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
  • Prior therapy defined as 1 prior systemic therapy for advanced disease
  • Documented disease progression during or following most first line therapy for advanced disease
  • Adequate hematologic, hepatic, renal function

Exclusion Criteria:

  • Epidermal growth factor receptor (EGFR) mutations
  • Anaplastic lymphoma kinase (ALK) translocations
  • Predominantly squamous, adenosquamous or unclear histologic type
  • Active or untreated central nervous system (CNS) metastases
  • Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
  • Serious cardiac illness or medical conditions
  • Pregnant or lactating women
  • Uncontrolled intercurrent illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798485

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Associates PC- NAHOA
Flagstaff, Arizona, United States, 86001
Arizona Oncology Associates, PC- NAHOA
Prescott Valley, Arizona, United States, 86314
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
United States, California
Pacific Cancer Medical Center, Inc
Anaheim, California, United States, 92801
Comprehensive Blood & Cancer Center
Bakersfield, California, United States, 93309
City of Hope Comprehensive Breast Cancer Center
Duarte, California, United States, 91010
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Loma Linda University Cancer Center
Loma Linda, California, United States, 92345
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
St. Joseph Hospital, Center for Cancer Prevention and Treatment
Orange, California, United States, 92868
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
UC Davis Medical Center - UC Davis Comprehensive Cancer
Sacramento, California, United States, 95817
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States, 93105-4230
City of Hope- South Pasadena
South Pasadena, California, United States, 91030
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Connecticut
Eastern Connecticut Hematology Associates
Norwich, Connecticut, United States, 06360
United States, Delaware
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States, 19713
United States, Florida
Lynn Cancer Institute Center for Hematology Oncology
Boca Raton, Florida, United States, 33486
Halifax Health - Medical Center
Daytona Beach, Florida, United States, 32114
University of Miami Health System Sylvester at Deerfield Beach
Deerfield Beach, Florida, United States, 33442-7753
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Baptist Health Medical Group Oncology, LLC
Miami, Florida, United States, 33176
University of South Florida - H. Lee Moffitt
Tampa, Florida, United States, 33612
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
United States, Illinois
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States, 62526
Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc
Fort Wayne, Indiana, United States, 46804
United States, Maryland
AAMC Oncology and Hematology
Annapolis, Maryland, United States, 21401
The Center for Cancer and Blood Disorders (CCBD) - Bethesda
Bethesda, Maryland, United States, 20817
The John R Marsh Cancer Center
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
United States, Minnesota
St. Luke's Hospital Duluth
Duluth, Minnesota, United States, 55805
Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
United States, Missouri
St. Louis Cancer Care, LLP - North County
Bridgeton, Missouri, United States, 63044
United States, Nevada
Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Jersey
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87109
United States, New York
North Shore Hematology Oncology Associates
East Setauket, New York, United States, 11733
Clinical Research Alliance
Lake Success, New York, United States, 11042
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
New Hanover Regional Medical Center - Zimmer Cancer Center
Wilmington, North Carolina, United States, 28401
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Tulsa Cancer Institute, PLLC
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States, 18840
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Prairie Lakes Healthcare System
Watertown, South Dakota, United States, 57201
United States, Tennessee
Erlanger Institute for Clinical Research
Chattanooga, Tennessee, United States, 37403
Associates In Oncology and Hematology
Chattanooga, Tennessee, United States, 37421
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Texas Oncology-Arlington North
Arlington, Texas, United States, 76012
Texas Oncology - Arlington South
Arlington, Texas, United States, 76014
Texas Oncology, P.A.
Beaumont, Texas, United States, 77702
Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75390
Texas Oncology, PA
Dallas, Texas, United States, 75246
Houston Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Millennium Oncology
Houston, Texas, United States, 77090
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78258
Cancer Care Centers Of South Texas
San Antonio, Texas, United States, 78217
Cancer Care Centers Of South Texas
San Antonio, Texas, United States, 78212
Texas Oncology - Sherman
Sherman, Texas, United States, 75090
United States, Washington
Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
Cancer Care Northwest
Spokane Valley, Washington, United States, 99216
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
United States, West Virginia
Mary Babb Cancer Center
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Green Bay Oncology
Green Bay, Wisconsin, United States, 54307
Green Bay Oncology, Ltd. - St. Mary's Site
Green Bay, Wisconsin, United States, 54303-3216
Austria
Landesklinikum Krems
Krems, Niederösterreich, Austria, 3500
Krankenhaus Der Barmherzigen Schwestern
Linz, Oberösterreich, Austria, 4010
Klinikum Wels-Grieskirchen
Wels, Oberösterreich, Austria, A-4600
Bezirkskrankenhaus Kufstein [Onkologie]
Kufstein, Tirol, Austria, A-6330
Allgemeines Krankenhaus Linz
Linz, Austria, 4021
Elisabeth Linz Hospital
Linz, Austria, 4021
Sozialmedizinisches Zentrum Baumgartner Höhe
Wien, Austria, 1145
Otto Wagner Spital
Wien, Austria, 1140
Belgium
AZ Sint-Maarten - Campus Leopoldstraat
Mechelen, Antwerpen, Belgium, 2800
Clinique Saint-Pierre Ottignies
Ottignies, Brabant Wallon, Belgium, 1340
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Hainaut, Belgium, 6000
INDC Entité Jolimontoise - Polyclinique de Jolimont
Haine St. Paul, Hainaut, Belgium, 1700
CHU Dinant Godinne UCL Namur
Yvoir, Namur, Belgium, 5533
Algemeen Stedelijk Ziekenhuis - Campus Aalst
Roeselaere, West-Vlaanderen, Belgium, 8800
Cliniques Universitaire Saint-Luc
Bruxelles, Belgium, 1200
CHR de la Citadelle - Site Citadelle
Liège, Belgium, 4000
Bosnia and Herzegovina
Clinical Centre Banja Luka
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Center Tuzla
Tuzla, Tuzlanski kanton, Bosnia and Herzegovina, 75000
Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina, 88108
Clinical Center University of Sarajevo, Clinic of Oncology
Sarajevo, Bosnia and Herzegovina, 71000
University Clinical Centre Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
University Clinical Center Tuzla
Tuzla, Bosnia and Herzegovina, 75000
Kantonalna bolnica Zenica
Zenica, Bosnia and Herzegovina, 72000
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, MG5 2M9
Canada, Quebec
Mc Gill University-MUHC
Montreal, Quebec, Canada, H2W 1S6
Croatia
University Hospital Center Zagreb
Zagreb, Grad Zagreb, Croatia, 10 000
Opca bolnica Pula
Pula, Istarska županija, Croatia, 52000
Czech Republic
Fakultni nemocnice Olomouc
Olomouc, Czech Republic, 775 20
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czech Republic, 708 52
Vseobecna fakultni nemocnice v Praze
Prague, Czech Republic, 128 08
Nemocnice Na Bulovce
Prague, Czech Republic, 180 81
France
CHI des Alpes du Sud
Gap, Hautes-Alpes, France, 5000
Centre D'Oncologie Du Pays Basque
Bayonne, Pyrénées-Atlantiques, France, 64100
Centre Hosptalier De Villefranche-Sur-Saone
Villefranche Sur Saone, Rhône, France, 69655
Chi creteil
Creteil, Val-de-Marne, France, 94010
Chu De Grenoble - Hopital Michallon
Grenoble, France, 38700
Centre Léon Bérard
Lyon, France, 69373
Groupe Hospitalier Cochin
Paris, France, 75679
Centre Hospitalier Universitaire de Rennes - Hopital d
Rennes, France, 35033
Hôpital Charles Nicolle
Rouen, France, 76000
CHRU de Strasbourg
Strasbourg, France, 67091
Germany
Universitätsklinikum Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Universiaetsklinikum Ulm
Ulm, Baden-Württemberg, Germany, 89081
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, Baden-Württemberg, Germany, 78052
Asklepios Fachklinik München-Gauting
Gauting, Bayern, Germany, 82131
Klinikum Bogenhausen
Muenchen, Bayern, Germany, 81925
Gesundheitszentrum Wetterau
Bad Nauheim, Hessen, Germany, 61231
Johann Wolfgang Goethe University Clinic Frankfurt
Frankfurt, Hessen, Germany, 60590
Johann Wolfgang Goethe University Clinic Frankfurt
Frankfurt, Hessen, Germany, D-60590
Klinikum Kassel
Kassel, Hessen, Germany, 34125
Kliniken der Stadt Köln gGmbH
Köln, Nordrhein-Westfalen, Germany, 51109
Universitaetsklinikum des Saarlandes
Homburg, Saarland, Germany, 66421
Universitätsklinikum Leipzig [Pneumologie]
Leipzig, Sachsen, Germany, 04103
Pneumologisches Forschungsinstitut an der Lungenclinic Gross
Großhansdorf, Schleswig-Holstein, Germany, 22927
MVZ Äerzteforum Seestraße
Berlin, Germany, 13347
Ev. Krankenhaus Bielefeld
Bielefeld, Germany, 33611
Klinikum Frankfurt An Der Oder
Frankfurt/Oder, Germany, 15236
Practice Laack
Hamburg, Germany, 20251
Unikl. Schleswig-Holstein - Lübeck
Lübeck, Germany, 23538
J. Gutenberg Uni.Mainz
Mainz, Germany, 55101
Medizinische Fakultät Mannheim Uni Heidelberg
Mannheim, Germany, 68167
Gemeinschaftspraxis fuer Haematologie und Onkologie
Muenster, Germany, 48149
Klinikum Offenbach GmbH
Offenbach, Germany, 63069
Hungary
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó
Deszk, Csongrád, Hungary, 6772
Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, Fejér, Hungary, 8000
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, Pest, Hungary, 1145
Semmelweis Egyetem
Budapest, Hungary, 1125
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, Hungary, 1529
Békés Megyei Pándy Kálmán Kórház
Gyula, Hungary, 5703
CRU Hungary Kft.
Miskolc, Hungary, 3529
Italy
Irccs Irst
Meldola, Forli, Italy, 47014
Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo
Viterbo, Lazio, Italy, 01100
Azienda Ospedaliera San Gerardo
Monza, Lombardia, Italy, 20900
CRO, IRCCS, Istituto Nazionale Tumori
Aviano, Pordenone, Italy, 33081
Azienda Policlinico Umberto I
Rome, Roma, Italy, 00161
Policlinico S.Orsola Malpighi, AOU di Bologna
Bologna, Italy, 40138
AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
Genova, Italy, 16132
Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a
Milano, Italy, 20141
Iov-Irccs
Padova, Italy, 35128
Ospedale S.Maria della Misericordia, AO di Perugia, Universi
Perugia, Italy, 06156
Ospedale Guglielmo da Saliceto, AUSL Piacenza
Piacenza, Italy, 29100
Istituti Fisioterapici Ospitalieri Regina Elena
Roma, Italy, 00144
Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona
Verona, Italy, 37134
Netherlands
Ziekenhuis Assen
Assen, Drenthe, Netherlands, 9401 RK
Ziekenhuis St Jansdal
Harderwijk, Gelderland, Netherlands, 3844 DG
Gelre Ziekenhuis Zutphen
Zutphen, Gelderland, Netherlands, 7207 AE
academisch ziekenhuis Maastricht
Maastricht, Limburg, Netherlands, 6229 HX
Isala Klinieken Zwolle
Zwolle, Overijssel, Netherlands, 8025 AB
Sint Antoniusziekenhuis, location Utrecht
Utrecht, Netherlands, 3543 AZ
Poland
Wojewodzki Szpital Specjalistyczny im. M.Kopernika
Lodz, Lodzkie, Poland, 93-513
Medica Pro Familia Sp. z o.o. S.K.A.
Krakow, Malopolskie, Poland, 31-002
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Mazowieckie, Poland, 05-400
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
Warszawa, Mazowieckie, Poland, 02-781
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie, Poland, 15-540
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
Lomza, Podlaskie, Poland, 18-400
Szpital Wojewodzki Zespolony
Elblag, Warminsko-mazurskie, Poland, 82-300
NZOZ Med Polonia
Poznan, Wielkopolskie, Poland, 60-693
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
Poznan, Wielkopolskie, Poland, 60569
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, Poland, 10-357
Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach
Pilchowice, Poland, 44145
Szpital Specjalistyczny
Prabuty, Poland, 82-550
Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, Romania, 050098
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
Bucharest, Romania, 022328
Spitalul Clinic Coltea
Bucuresti, Romania, 030171
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca
Cluj Napoca, Romania, 400015
Medisprof
Cluj Napoca, Romania, 400058
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca
Cluj-Napoca, Romania, 400015
Centrul de Oncologie Sf. Nectarie
Craiova, Romania, 200385
Institutul Regional de Oncologie Iasi
Iasi, Romania, 700483
Oncomed
Timisoara, Romania, 300239
Russian Federation
Synta Pharmaceuticals Investigational Site
Chelyabinsk, Russian Federation, 454087
Synta Pharmaceuticals Investigational Site
Ekaterinburg, Russian Federation, 620036
Synta Pharmaceuticals Investigational Site
Ivanovo, Russian Federation, 153040
Synta Pharmaceuticals Investigational Site
Izhevsk, Russian Federation, 426067
Synta Pharmaceuticals Investigational Site
Kemerovo, Russian Federation, 650036
Synta Pharmaceuticals Investigational Site
Krasnoyarsk, Russian Federation, 660133
Synta Pharmaceuticals Investigational Site
Kursk, Russian Federation, 305035
Synta Pharmaceuticals Investigational Site
Lipetsk, Russian Federation, 398005
Synta Pharmaceuticals Investigational Site
Moscow, Russian Federation, 115478
Synta Pharmaceuticals Investigational Site
Nizhny Novgorod, Russian Federation, 603081
Synta Pharmaceuticals Investigational Site
Novosibirsk, Russian Federation, 630047
Synta Pharmaceuticals Investigational Site
Omsk, Russian Federation, 644013
Synta Pharmaceuticals Investigational Site
Orel, Russian Federation, 302020
Synta Pharmaceuticals Investigational Site
Rostov-on-Don, Russian Federation, 344037
Synta Pharmaceuticals Investigational Site
Samara, Russian Federation, 443031
Synta Pharmaceuticals Investigational Site
Saransk, Russian Federation, 430032
Synta Pharmaceuticals Investigational Site
Sochi, Russian Federation, 354057
Synta Pharmaceuticals Investigational Site
St. Petersburg, Russian Federation, 194017
Synta Pharmaceuticals Investigational Site
St. Petersburg, Russian Federation, 197758
Synta Pharmaceuticals Investigational Site
St. Petersburg, Russian Federation, 198255
Synta Pharmaceuticals Investigational Site
Stavropol, Russian Federation, 355047
Synta Pharmaceuticals Investigational Site
Ufa, Russian Federation, 450000
Synta Pharmaceuticals Investigational Site
Ufa, Russian Federation, 450054
Serbia
Clinical Centre of Serbia
Beograd, Belgrade, Serbia, 11000
Clinical Centre Nis
Nis, Nišavski okrug, Serbia, 18000
Institute for Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Institute for pulmonary diseases of Vojvodine
Sremska Kamenica, Serbia, 21204
Clinical Center Kragujevac
Kragujevac, Šumadijski okrug, Serbia, 34 000
Slovenia
Univerzitetna klinika za pljucne bolesti in alergijo Golnik
Golnik, Slovenia, 4204
Onkoloski institut Ljubljana
Ljubljana, Slovenia, 1000
Spain
Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera
La Coruña, A Coruña, Spain, 15006
Synta Pharmaceuticals Investigational Site
Málaga, Andalucía, Spain, 29010
Synta Pharmaceuticals Investigational Site
Oviedo, Asturias, Spain, 33006
H. Son Llàtzer
Palma de Mallorca, Baleares, Spain, 07198
Hospital de Mataró, Consorci Sanitari del Maresme
Mataró, Barcelona, Spain, 08304
Synta Pharmaceuticals Investigational Site
Santander, Cantabria, Spain, 39008
Onkologikoa
San Sebastian, Guipuzcoa, Spain, 20014
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
H.U. Vall d'Hebrón
Barcelona, Spain, 08035
Synta Pharmaceuticals Investigational Site
Barcelona, Spain, 08036
H.U. Reina Sofía
Córdoba, Spain, 14004
Synta Pharmaceuticals Investigational Site
Girona, Spain, 17007
Synta Pharmaceuticals Investigational Site
Madrid, Spain, 28033
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Synta Pharmaceuticals Investigational Site
Madrid, Spain, 28223
F. Jiménez Diaz
Madrid, Spain, 28040
Synta Pharmaceuticals Investigational Site
Madrid, Spain, 28041
Hospital Madrid Norte Sanchinarro
Madrid, Spain, 28050
Synta Pharmaceuticals Investigational Site
Madrid, Spain, 28034
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 460026
Ukraine
Synta Pharmaceuticals Investigational Site
Cherkasy, Ukraine, 18009
Synta Pharmaceuticals Investigational Site
Chernivtsi, Ukraine, 58013
Synta Pharmaceuticals Investigational Site
Dnepropetrovsk, Ukraine, 49102
Synta Pharmaceuticals Investigational Site
Donetsk, Ukraine, 83087
Synta Pharmaceuticals Investigational Site
Donetsk, Ukraine, 83092
Synta Pharmaceuticals Investigational Site
Ivano-Frankivsk, Ukraine, 76000
Synta Pharmaceuticals Investigative Site
Kharkiv, Ukraine, 61070
Synta Pharmaceuticals Investigational Site
Khmelnytskyi, Ukraine, 29009
Synta Pharmaceuticals Investigational Site
Kirovohrad, Ukraine, 25011
Synta Pharmaceuticals Investigational Site
Kryvyi Rih, Ukraine, 50048
Synta Pharmaceuticals Investigational Site
Kyiv, Ukraine, 03115
Synta Pharmaceuticals Investigational Site
Makiivka, Ukraine, 86120
Synta Pharmaceuticals Investigational Site
Poltava, Ukraine, 36011
Synta Pharmaceuticals Investigational Site
Simferopol, Ukraine, 95023
Synta Pharmaceuticals Investigational Site
Sumy, Ukraine, 40022
Synta Pharmaceuticals Investigational Site
Uzhhorod, Ukraine, 88014
Synta Pharmaceuticals Investigational Site
Vinnytsia, Ukraine, 21021
United Kingdom
Synta Pharmaceuticals Investigational Site
Truro, Cornwall, United Kingdom, TR1 3LJ
Synta Pharmaceuticals Investigational Site
Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
Synta Pharmaceuticals Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Synta Pharmaceuticals Investigational Site
Swindon, Wiltshire, United Kingdom, SN3 6BB
Synta Pharmaceuticals Investigational Site
Cardiff, United Kingdom, CF14 2TL
Synta Pharmaceuticals Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Synta Pharmaceuticals Investigational Site
Leicester, United Kingdom, LEI 5WW
Synta Pharmaceuticals Investigational Site
London, United Kingdom, SE1 9RT
Synta Pharmaceuticals Investigational Site
London, United Kingdom, SW3 6JJ
Synta Pharmaceuticals Investigational Site
London, United Kingdom, W6 8RF
Synta Pharmaceuticals Investigational Site
Nottingham, United Kingdom, NG5 1PB
Synta Pharmaceuticals Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01798485     History of Changes
Other Study ID Numbers: 9090-14  2012-004349-34 
Study First Received: February 4, 2013
Results First Received: March 7, 2016
Last Updated: May 26, 2016
Health Authority: United States: Food and Drug Administration
Austria: Austrian Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Bosnia: Federal Ministry of Health
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016