Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer (Mainsail)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00988208
First received: October 1, 2009
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.


Condition Intervention Phase
Prostate Cancer
Drug: Lenalidomide
Drug: Docetaxel
Drug: Prednisone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC)

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization until death from any cause up to the cut-off date of 13 January 2012 ] [ Designated as safety issue: No ]
    Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Randomization until disease progression or death from any cause up to cut-off date of 13 Jan 2012; maximum time on study approximately 26 months ] [ Designated as safety issue: No ]
    PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by RECIST Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan

  • Objective Response Rate (ORR) of Measurable and/or Non-measurable Disease as Determined by Investigators According to RECIST Version 1.1 Criteria [ Time Frame: Day 1 to data cut-off 13 January 2012; maximum time on study approximately 26 months ] [ Designated as safety issue: No ]
    Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response. RECIST Criteria 1.1 defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones

  • Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: The maximum duration on study drug was 93 weeks, which includes the time from the first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut-off date of 13 January 2012 ] [ Designated as safety issue: Yes ]
    A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and Severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;


Enrollment: 1059
Study Start Date: November 2009
Estimated Study Completion Date: November 2016
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel, Prednisone, Lenalidomide (DPL)
25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle
Drug: Lenalidomide
25 mg lenalidomide orally once each day on Days 1-14
Other Names:
  • CC-5013
  • Revlimid
Drug: Docetaxel
75 mg/m2 intravenous docetaxel on Day 1
Other Name: Taxotere
Drug: Prednisone
5 mg prednisone orally twice daily on each day of the treatment cycle
Other Name: There are multiple brand names for prednisone.
Experimental: Docetaxel and Prednisone (DP)
Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle
Drug: Docetaxel
75 mg/m2 intravenous docetaxel on Day 1
Other Name: Taxotere
Drug: Prednisone
5 mg prednisone orally twice daily on each day of the treatment cycle
Other Name: There are multiple brand names for prednisone.
Drug: Placebo
Oral placebo once each day on Days 1-14 of the treatment cycle

Detailed Description:

In November 2011, the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival (OS) and recommended that the study be stopped. The study was terminated in accordance with this recommendation. All sites were instructed to immediately discontinue all patients from experimental lenalidomide/placebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation. Subsequently, Protocol Amendment 3 was issued to provide for the following:

To continue to collect information on Second Primary Malignancies (SPMs) and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up.

To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator discretion. For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval, an additional two cycles were provided.

All references to dosing and study procedures pertaining to the safety, efficacy, and exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol Amendment 3.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must sign an Informed Consent Form (ICF)
  2. Males ≥ 18 years of age
  3. Able to adhere to the study visit schedule and requirements of the protocol
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  5. Life expectancy of ≥ 12 weeks
  6. Willingness to participate in Patient-Reported Outcomes assessments
  7. Serum testosterone levels < 50 ng/dL
  8. Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
  9. Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ≥2 new bone lesions
  10. Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
  11. Refrain from donating blood or semen as defined by protocol

Exclusion Criteria:

  1. A history of clinically significant disease that places subject at an unacceptable risk for study entry
  2. Prior Therapy with thalidomide, lenalidomide or pomalidomide
  3. Prior chemotherapy for prostate cancer
  4. Use of any other experimental drug or therapy within 28 days prior to randomization
  5. Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
  6. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
  7. Surgery within 28 days prior to randomization
  8. Concurrent anti-androgen therapy
  9. Abnormal serum chemistry or hematology laboratory values
  10. Significant active cardiac disease within the previous 6 months:
  11. Thrombotic or thromboembolic events within the past 6 months:
  12. History of peripheral neuropathy of ≥grade 2
  13. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  14. Paraplegia
  15. History of Central nervous system (CNS) or brain metastases
  16. History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin
  17. Concurrent use of alternative cancer therapies
  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: NCT00988208

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Associates, P.C.
Phoenix, Arizona, United States, 85016
Northern AZ Hematology and Oncology Assoc
Sedona, Arizona, United States, 86336
Arizona Oncology
Tucson, Arizona, United States, 85710
United States, California
City of Hope Cancer Center
Duarte, California, United States, 91010-3000
Southwest Cancer Center - Escondido
Escondido, California, United States, 92025
Scripps Cancer Center - Clinical Research
La Jolla, California, United States, 92037
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
The Angeles Clinc and Research Institute
Los Angeles, California, United States, 90025
University of Southern California
Los Angeles, California, United States, 90033
Prostate Oncology Specialists
Marina Del Rey, California, United States, 90292
Stanford University Medical Center
Stanford, California, United States, 94035-5821
United States, Colorado
Rocky Mountain Cancer Centers-Colorado Springs/Circle
Colorado Springs, Colorado, United States, 80909
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
Melbourne Internal Medicine Associates
Melbourne, Florida, United States, 32901
Advanced Medical Specialties
Miami, Florida, United States, 33176
Florida Cancer Institute - New Hope
New Port Richey, Florida, United States, 34655
Ocala Oncology Center
Ocala, Florida, United States, 34474
Cancer Centers of Florida, P.A.- West Gore Street
Orlando, Florida, United States, 32806
South Florida Oncology - Hematology
Tamarac, Florida, United States, 33321
Palm Beach Cancer Institute, LLC
West Palm Beach, Florida, United States, 33401
United States, Illinois
Cancer Care and Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Louisiana
Hematology and Oncology Specialist, LLC
Metairie, Louisiana, United States, 70006
United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
United States, Minnesota
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Summit Medical Group/Overlook Oncology Center
Berkeley Heights, New Jersey, United States, 07922
Hematology-Oncology Associates of NNJ, P
Morristown, New Jersey, United States, 07960
Hematology Oncology Associates of South Jersey
Mount Holly, New Jersey, United States, 08060
United States, New Mexico
Northwest Cancer Specialists, P.C.
Albuquerque, New Mexico, United States, 87109
United States, New York
New York Oncology Hematology P.C.
Albany, New York, United States, 12208
Weill Cornell Medical College Dr. Feldman's Office
New York, New York, United States, 10065
Columbia Univ Medical Center
New York, New York, United States, 10032
United States, North Carolina
New Bern Cancer Care
New Bern, North Carolina, United States, 28562
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, North Dakota
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States, 29401
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Cookeville Regional Medical Center
Cookeville, Tennessee, United States, 38501
Sarah Cannon Research Institute UK
Nashville, Tennessee, United States, 37203-1632
United States, Texas
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, United States, 79106
TX Onc, PA- Arlington
Arlington, Texas, United States, 76012
Texas Oncology, PA
Austin, Texas, United States, 78758
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology, P.A.-Fort Worth
Fort Worth, Texas, United States, 76104
Texas Oncology, PA - Longview
Longview, Texas, United States, 75601
Allison Cancer Center
Midland, Texas, United States, 79701
Texas Oncology, P.A. - Paris
Paris, Texas, United States, 75460
Southlake Oncology
Southlake, Texas, United States, 76092
Texas Oncology, P.A. - Tyler
Tyler, Texas, United States, 75702
Texas Oncology Deke Slayton Cancer Center
Webster, Texas, United States, 77598
Texas Oncology-Texoma Cancer Center
Wichita Falls, Texas, United States, 76310
United States, Vermont
Veterans Education and Research Association of Northern New England, Inc.
White River Junction, Vermont, United States, 05009
United States, Virginia
Cancer Outreach Associates
Abingdon, Virginia, United States, 24211
Fairfax Northern Virginia Hematology/Oncology
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
United States, Washington
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States, 99336
VA Puget Sound HCS Seattle Division
Seattle, Washington, United States, 98108-1532
Evergreen Hematology and Oncology
Spokane, Washington, United States, 99218
Australia
Royal Adelaide Hospital
Adelaide, Australia, SA 5000
Flinders Medical Centre
Bedford Park, Australia, 5042
Chris O'Brien Lifehouse
Camperdown, Australia, NSW 2050
Sir Charles Gairdner Hospital
Nedlands, Australia, 6009 WA
Royal Melbourne Hospital
Parkville, Australia, VIC 3050
Port Macquarie Base Hospital
Port Macquarie, Australia, NSW 2444
Redcliffe Hospital
Redcliffe, Australia, QLD 4020
Royal North Shore Hospital
St Leonards, Australia, 2065
Newcastle Calvary Mater Hospital
Waratah, Australia, 2298
Westmead Hospital
Westmead, Australia, NSW 2145
Border Medical Oncology
Wodonga, Australia, 3690
The Queen Elizabeth Hospital
Woodville South, Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Australia, QLD 4102
Austria
Medical University of Graz
Graz, Austria, 8036
Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
Krankenhaus der Barmherzigen Brueder
Vienna, Austria, 1020
Medizinische Universität Wien
Wien, Austria, 1090
Belgium
ZNA Middelheim
Antwerpen, Belgium, 2020
Hôpital Erasme
Brussels, Belgium, 1070
Edith Cavell Clinic
Bruxelles, Belgium, 1180
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven
Leuven, Belgium, 3000
AZ Nikolaas
Sint-Niklaas, Belgium, 9100
Canada, Ontario
The Health Institute for Men CMX Research Inc
Toronto, Ontario, Canada, M1P 2T7
Canada, Quebec
Les Urologues Specialises
Montreal, Quebec, Canada, H2X 1N8
Czech Republic
Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.
Chomutov, Czech Republic, 430 12
Fakultni nemocnice Motol
Prague 5, Czech Republic, 150 06
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
Usti Nad Labem, Czech Republic, 40113
Denmark
Århus Universitets hospital
Aarhus C, Denmark, 8000
Herlev Hospital
Herlev, Denmark, 2730
Rigshospitalet University Hospital
Kobenhavn, Denmark, 2100
Odense Universitetshospital
Odense C, Denmark, 5000
France
CRLCC Paul Papin
Angers 49, France, 49933
Institut Bergonié
Bordeaux, France, 33076
Centre Georges Francois Leclerc
Dijon Cedex, France, 21079
Clinique Victor Hugo
Le Mans, France, 72000
Centre Oscar Lambret
Lille 59, France, 59020
Centre Leon Berard
Lyon, France, 69373
Clinique de Valdegour
Nimes, France, 30900
CHU de Poitiers
Poitiers Cedex, France, 86021
Centre Eugene Marquis
Rennes Cedex, France, 35042
CRLCC Centre René Gauducheau
Saint Herblain 44, France, 44805
Institut de Cancérologie de la Loire
Saint Priest en Jaroz, France, 42270
Hôpital Civil de Strasbourg
Strasbourg, France, 67091
CHRU Hôpital Bretonneau
Tours Cedex, France, 37044
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Vivantes Klinikum am Urban
Berlin, Germany, 10967
Medizinisches Zentrum Bonn-Friedensplatz
Bonn, Germany, 53111
Diakonissenkrankenhaus Dessau gGmbH
Dessau-Rosslau, Germany, 06846
Universitaetsklinikum Duesseldorf
Duesseldorf, Germany, 40225
Krankenhaus Nordwest
Frankfurt a.M., Germany, 60488
Onkologische Praxis Freiburg
Freiburg, Germany, 79106
IORC- Innovation Onkologie Research and Consulting GmbH
Hamburg, Germany, 22081
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Praxis fuer Haematologie und Onkologie Koblenz
Koblenz, Germany, 56068
Vituro GmbH & Co KG
Leipzig, Germany, 4277
TU München - Klinikum rechts der Isar
München, Germany, 81675
Universitaetsklinikum Muenster
Münster, Germany, 48149
University-Hospital Tübingen
Tuebingen, Germany, 72076
Universitätsklinikum Ulm
Ulm, Germany, 89075
Greece
Agioi Anargyroi Hospital
Athens, Greece, 14564
Alexandra General Hospital of Athens
Athens, Greece, 11528
University Hospital of Larissa
Larissa, Greece, 41110
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Greece, 56429
Hungary
Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, Hungary, 1106
Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.
Budapest, Hungary, 1076
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, Hungary, 3526
Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
Pecs, Hungary, 7623
Israel
The Soroka University Medical Center
Beer Sheva, Israel, 84101
Rambam Health Care Campus
Haifa, Israel, 31096
Rabin Medical Center
Petach Tikva, Israel, 49100
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy, 70124
Ordine Mauriziano
Candiolo, Italy, 10023
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, Italy, 23100
Ospedale Vito Fazzi
Lecce, Italy, 73100
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei T
Meldola, Italy, 47014
Ospedale di Mirano
Mirano (VE), Italy, 30035
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Ospedale degli Infermi Rimini
Rimini, Italy, 47900
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00149
Azienda Ospedaliero-Universitaria Santa Maria della Miserico
Udine, Italy, 70124
Mexico
Hospital Angeles Lindavista
D.f, Df, Mexico, 07760
Consultorio de Especialidad en Urologia Privado
Durango, DGO, Mexico, 34000
Hospital Fatima
Sinaloa, SIN, Mexico, 81200
Consultorio Privado- Dr Jose Arturo Rodriguez Rivera
Zapopan, JAL, Mexico, 45040
Netherlands
VU University Medical Center (VU Medisch Centrum)
Amsterdam, Netherlands, 1081 HV
Ziekenhuis Rijnstate
Arhem, Netherlands, 6800 TA
Amphia Ziekenhuis Molengracht
Breda,, Netherlands, 4818 CK
HagaZiekenhuis
Den Haag, Netherlands, 2545 CH
Gemini Ziekenhuis
Den Helder, Netherlands, 1782 GZ
Albert Schweitzer Ziekenhuis Amstelwijck
Dordrecht, Netherlands, 3317 NM
Catharina Ziekenhuis
Eindhoven, Netherlands, 5632 EJ
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 ZA
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229 HX
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Netherlands, 3435 CM
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GD
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Twee Steden Ziekenhuis Tilburg
Tilburg, Netherlands, 5042 AD
VieCuri Medisch Centrum Venlo
Venlo, Netherlands, 5912 BL
Isala Klinieken
Zwolle, Netherlands, 8025 AB
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Regionalny Osrodek Onkologiczny WSS im. M. Kopernika
Lodz, Poland, 93-509
NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
Olsztyn, Poland, 10-513
ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii
Olsztyn, Poland, 10-228
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
Rybnik, Poland, 44-200
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Wroclaw, Poland, 50-981
Russian Federation
Moscow Oncology Clinical Dispensary #1
Moscow, Russian Federation, 105005
Medical Radiology Research Centre RAMS
Obninsk, Russian Federation, 249036
State Institution of Heath Omsk Regional Oncology Dispensary
Omsk, Russian Federation, 644013
Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg
Pesochny vlg St. Petersburg, Russian Federation, 197758
NSHI "Dorozhnaya Clinical Hospital of OAO "Russian Railways"
Rostov-on-Don, Russian Federation, 344011
Oncology Dispensary #2 of Krasnodar Region
Sochi, Russian Federation, 354057
Yaroslavl Regional Clinical Oncology Hospital
Yaroslavl, Russian Federation, 150054
South Africa
Groote Schuur Hospital
Cape Town, W Cape, South Africa, 7925
The Oncology Centre Durban
Durban, KZ-Natal, South Africa, 4091
Westridge Medical Centre
Durban, KZ-Natal, South Africa, 4091
Netcare Oncology and Interventional Centre
Goodwood, W Cape, South Africa, 7460
Dr. H. Malan
Polokwane, South Africa, 699
Pretoria Urology Hospital
Pretoria, South Africa, 0083
Spain
Hospital del Mar
Barcelona, Spain, 08003
Hospital Durán i Reynals - Instituto Catalàn de Oncologìa (ICO)
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Arnau de Vilanova
Lérida, Spain, 25198
Hospital 12 de Octobre
Madrid, Spain, 28041
HCU Virgen de la Victoria
Malaga, Spain, 29010
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Mutua de Terrassa
Terrassa (Barcelona), Spain, 08221
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sweden
Länssjukhuset Ryhov
Jönköping, Sweden, 55185
Norrlands Universitetssjukhus
Umeå, Sweden, 90185
Centrallasarettet Västerås
Västerås, Sweden, 721 89
United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Bebington, Wirral, United Kingdom, CH63 4JY
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 2QQ
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Guy's and St Thomas' Hospital - London
London, United Kingdom, SE1 9RT
St George's Hospital
London, United Kingdom, SW17 0QT
Christie NHS Trust Hospital
Manchester, United Kingdom, M20 4BX
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Scunthorpe, United Kingdom, DN15 7BH
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Debora Barton, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00988208     History of Changes
Other Study ID Numbers: CC-5013-PC-002, EudraCT Number 2008-007969-23
Study First Received: October 1, 2009
Results First Received: June 27, 2013
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Denmark: Danish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Czech Republic: State Institute for Drug Control
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Brazil: National Health Surveillance Agency
Mexico: Federal Commission for Sanitary Risks Protection
Greece: National Organization of Medicines
Sweden: Medical Products Agency

Keywords provided by Celgene Corporation:
Castrate-Resistant Prostate Cancer
Revlimid
Lenalidomide

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Lenalidomide
Thalidomide
Prednisone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 16, 2014