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:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00988208
First received: October 1, 2009
Last updated: September 27, 2012
Last verified: September 2012
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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 |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Overall Survival [ Time Frame: Cycle 1 Day 1 until subject death ] [ Designated as safety issue: No ]Number of participants who survive
Secondary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: Cycle 1 day 1 until disease progression ] [ Designated as safety issue: No ]Number of participants who survive without progressing
- Objective Response Rate [ Time Frame: Cycle 1 day 1 until best measurable response ] [ Designated as safety issue: No ]
- Safety of lenalidomide in combination with docetaxel and prednisone [ Time Frame: baseline until 28 days after last study dose ] [ Designated as safety issue: Yes ]Number of participants with adverse events
| 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:
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:
- Must sign an Informed Consent Form (ICF)
- Males ≥ 18 years of age
- Able to adhere to the study visit schedule and requirements of the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Life expectancy of ≥ 12 weeks
- Willingness to participate in Patient-Reported Outcomes assessments
- Serum testosterone levels < 50 ng/dL
- Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
- 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
- Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
- Refrain from donating blood or semen as defined by protocol
Exclusion Criteria:
- A history of clinically significant disease that places subject at an unacceptable risk for study entry
- Prior Therapy with thalidomide, lenalidomide or pomalidomide
- Prior chemotherapy for prostate cancer
- Use of any other experimental drug or therapy within 28 days prior to randomization
- Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
- Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
- Surgery within 28 days prior to randomization
- Concurrent anti-androgen therapy
- Abnormal serum chemistry or hematology laboratory values
- Significant active cardiac disease within the previous 6 months:
- Thrombotic or thromboembolic events within the past 6 months:
- History of peripheral neuropathy of ≥grade 2
- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- Paraplegia
- History of Central nervous system (CNS) or brain metastases
- 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
- Concurrent use of alternative cancer therapies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988208
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| United States, Arizona | |
| Hematology Oncology Associates | |
| Phoenix, Arizona, United States, 85012 | |
| Arizona Oncology Associates D.B.A. Hematology Oncology Physicians & Extenders | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| City of Hope Cancer Center | |
| Duarte, California, United States, 91010 | |
| Southwest Cancer Care | |
| Escondido, California, United States, 92025 | |
| VA Long Beach Healthcare System | |
| Long Beach, California, United States, 90822 | |
| University of Southern California Medical Center | |
| Los Angeles, California, United States, 90033 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5826 | |
| United States, Colorado | |
| Rocky Mountain Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| United States, Florida | |
| 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, 34471 | |
| Cancer Centers of Florida, P.A. | |
| Ocoee, Florida, United States, 34761 | |
| South Florida Hematology Oncology Group | |
| Tamarac, Florida, United States, 33321 | |
| Palm Beach Cancer Institute | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Illinois | |
| Cancer Care & Hematology Specialists of Chicagoland | |
| Niles, Illinois, United States, 60714 | |
| Advocate Lutheran General Hospital | |
| Niles, Illinois, United States, 60714 | |
| 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, P.A. | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Missouri | |
| Missouri Cancer Associates | |
| Columbia, Missouri, United States, 65201 | |
| United States, Nevada | |
| Comprehensive Cancer Center of Nevada | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New Jersey | |
| Summit Medical Group | |
| Berkeley Heights, New Jersey, United States, 07922 | |
| Hematology-Oncology Associates of NNJ P.A. | |
| Morristown, New Jersey, United States, 07960 | |
| Hematology Oncology Associates of South Jersey | |
| Mt. Holly, New Jersey, United States, 08060 | |
| United States, New York | |
| New York Oncology Hematology, P.C. | |
| Albany, New York, United States, 12208 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10065 | |
| 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 | |
| Legacy Pharma Research | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Oncology Hematology Care, Inc. | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Oregon | |
| Northwest Cancer Specialists-Tualatin | |
| Tualatin, Oregon, United States, 97062 | |
| 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, 29201 | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| Cookeville Regional Medical Center | |
| Cookeville, Tennessee, United States, 38501 | |
| Sarah Cannon Research Institute | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Texas Oncology, P.A. | |
| Amarillo, Texas, United States, 79106 | |
| Texas Oncology, P.A. | |
| Arlington, Texas, United States, 76014 | |
| Texas Oncology North Austin | |
| Austin, Texas, United States, 78759 | |
| Baylor Sammons Cancer Center | |
| Dallas, Texas, United States, 75246 | |
| Texas Oncology, P.A. | |
| Fort Worth, Texas, United States, 76104 | |
| Longview Cancer Center | |
| Longview, Texas, United States, 75601 | |
| Allison Cancer Center | |
| Midland, Texas, United States, 79701 | |
| Texas Oncology, P.S. - 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, P.A. | |
| Webster, Texas, United States, 77598 | |
| Texoma Cancer Center | |
| Wichita Falls, Texas, United States, 76310 | |
| United States, Vermont | |
| VA Medical Center | |
| White River Junction, Vermont, United States, 05009 | |
| United States, Virginia | |
| Oncology and Hem Associates of SW VA, Inc. | |
| Christiansburg, Virginia, United States, 24073 | |
| Fairfax Northern VA Hem-Onc PC | |
| Fairfax, Virginia, United States, 22031 | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
| United States, Washington | |
| Columbia Basin Hematology and Oncology | |
| Kennewick, Washington, United States, 99336 | |
| VA Puget Sound Health Care System | |
| Seattle, Washington, United States, 98108 | |
| Australia, New South Wales | |
| Port Macquarie Base Hospital | |
| Port Macquarie, New South Wales, Australia, 2444 | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia | |
| Flinders Medical Centre | |
| Bedford Park, Australia | |
| Royal Prince Alfred Hospital | |
| Camperdown, Australia | |
| Royal Melbourne Hospital | |
| Parkville, Australia | |
| Redcliffe Hospital | |
| Redcliffe, Australia | |
| Royal North Shore Hospital | |
| St. Leonards, Australia | |
| Sir Charles Gairdner Hospital | |
| Subiaco, Australia | |
| Calvary Mater Newcastle Hospital | |
| Waratah, Australia | |
| Border Medical Oncology | |
| Wodonga, Australia, 3690 | |
| The Queen Elizabeth Hospital | |
| Woodville South, Australia | |
| Austria | |
| Medical University of Graz | |
| Graz, Austria, 8036 | |
| Landeskrankenhaus Salzburg | |
| Salzburg, Austria, 5020 | |
| Krankenhaus der Barmherzigen Brueder | |
| Wien, Austria, 1020 | |
| University of Vienna | |
| Wien, Austria, 1090 | |
| Belgium | |
| ZNA Middelheim | |
| Antwerpen, Belgium, 2020 | |
| Clinique Edith Cavell | |
| Brussels, Belgium, 1180 | |
| Hôpital Erasme | |
| Brussels, Belgium, 1070 | |
| AZ Groeninge | |
| Kortrijk, Belgium, 8500 | |
| UZ Leuven | |
| Leuven, Belgium, 3000 | |
| AZ Niklaas | |
| Sint-Niklaas, Belgium, 9100 | |
| 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 | |
| Urologicke oddeleni Krajska zdravotni, a.s. | |
| Chomutov, Czech Republic, 430 12 | |
| Urologicka klinika Fakultni nemocnice v Motole | |
| Prague, Czech Republic, 5 150 06 | |
| Denmark | |
| Århus Universitetshospital | |
| Aarhus, Denmark, 8000 | |
| Herlev Hospital | |
| Herlev, Denmark, 2730 | |
| Rigshospitalet University Hospital | |
| Kobenhavn, Denmark, 2100 | |
| Odense Universitetshospital | |
| Odense, Denmark, 5000 | |
| France | |
| CRLCC Paul Papin | |
| Angers, France | |
| Institut Bergonié | |
| Bordeaux, France, 33076 | |
| Centre Georges Francois Leclerc | |
| Dijon, France, 21079 | |
| Clinique Victor Hugo | |
| Le Mans, France, 72000 | |
| Centre Oscar Lambret | |
| Lille, France, 59020 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| Clinique de Valdegour | |
| Nimes, France, 30900 | |
| CHU de Poitiers | |
| Poitiers, France, 86021 | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 | |
| CRLCC Centre René Gauducheau | |
| Saint Herblain, France, 44805 | |
| Institut de Cancerologie de la Loire | |
| Saint Priest en Jaroz, France, 42270 | |
| Hopital Civil de Strasbourg | |
| Strasbourg, France, 67091 | |
| CHRU Hôpital Bretonneau | |
| Tours, France, 37044 | |
| Institut Gustave Roussy | |
| Villejuif, France, 94805 | |
| Germany | |
| Vivantes Klinikum am Urban | |
| Berlin, Germany, 10967 | |
| Medizinisches Zentrum Bonn-Friedensplatz5 | |
| Bonn, Germany, 53111 | |
| Diakonissenkrankenhaus Dessau gGmbH | |
| Dessau-Rosslau, Germany, 06846 | |
| Universitaetsklinikum Duesseldorf | |
| Duesseldorf, Germany, 40225 | |
| Krankenhaus Nordwest | |
| Frankfurt, Germany, 60488 | |
| Onkologische Praxis Freiburg | |
| Freiburg, Germany, 79106 | |
| IORC | |
| Hamburg, Germany, 22081 | |
| Universitaetsklinikum Hamburg-Eppendorf | |
| Hamburg, Germany, 20246 | |
| Praxis fuer Haematologie und Onkologie Koblenz | |
| Koblenz, Germany, 56068 | |
| Vituro GmbH & Co KG | |
| Leipzig, Germany, 04109, SN | |
| Universitaetsklinikum Muenster | |
| Muenster, Germany, 48149 | |
| Klinikum rechts der Isar | |
| München, Germany, 81675 | |
| Universitaetsklinikum Tuebingen | |
| Tuebingen, Germany, 72076 | |
| Universitaetsklinikum Ulm | |
| Ulm, Germany, BW 89075 | |
| Greece | |
| General Hospital of Athens "Alexandra" | |
| Athens, Greece, 11528 | |
| Agioi Anargyroi Hospital | |
| Athens, Greece, 14564 | |
| University Hospital of Larissa | |
| Larissa, Greece, 41110 | |
| General Hospital of Thessaloniki "Papageorgiou" | |
| 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, 1106 | |
| 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, 10060 | |
| 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 Tumori | |
| Meldola, Italy, 47014 | |
| Ospedale di Mirano | |
| Mirano, 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 | |
| Mexico City, DF, Mexico, 07760 | |
| Consultorio Privado - Dr. Jose Arturo Rodriguez Rivera | |
| Zapopan, JAL, Mexico, 45040 | |
| Hospital Fatima | |
| Los Mochis, SIN, Mexico, 81200 | |
| Consultorio de Especialidad en Urologia Privado | |
| Durango, Mexico, 34000 | |
| Netherlands | |
| Medisch Centrum Leeuwarden | |
| Leeuwarden, AD, Netherlands, 8934 | |
| VieCuri Medisch Centrum Venlo | |
| Venlo, BL, Netherlands, 5912 | |
| Haga Ziekenhuis | |
| Den Haag, CH, Netherlands, 2545 | |
| Amphia Ziekenhuis Molengracht | |
| Breda, CK, Netherlands, 4818 | |
| St. Antonius Ziekenhuis Nieuwegein | |
| Nieuwegein, CM, Netherlands, 3435 | |
| Erasmus Medisch Centrum | |
| Rotterdam, GD, Netherlands, 3015 | |
| VU Medisch Centrum | |
| Amsterdam, HV, Netherlands, 1081 | |
| Jeroen Bosch Ziekenhuis Groot Ziekengasthuis | |
| 's-Hertogenbosch, RW, Netherlands, 5211 | |
| Leids Universitair Medisch Centrum | |
| Leiden, ZA, Netherlands, 2333 | |
| Ziekenhuis Rijnstate | |
| Arhem, Netherlands, 6800 TA | |
| Gemini Ziekenhuis | |
| Den Helder, Netherlands, 1782 GZ | |
| Catharina Ziekenhuis | |
| Eindhoven, Netherlands, 5632 EJ | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6229 HX | |
| Twee Steden Ziekenhuis | |
| Tilburg, Netherlands, 5042 AD | |
| Isala Klinieken | |
| Zwolle, Netherlands, 8025 AB | |
| Poland | |
| Public Autonomus Clinical Hospital Nol Medical University of Gdansk | |
| Gdansk, Poland, 80-119 | |
| Regionalny Osrodek Onkologiczny WSS im. M. Kopernika | |
| Lodz, Poland, 93-509 | |
| NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o | |
| Olsztyn, Poland, 10-513 | |
| Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i Administracji | |
| 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 | |
| NSHI "Dorozhnaya Clinical Hospital of OAO "Russian Railways" | |
| Rostov-on-Don, Russian Federation, 344011 | |
| Oncology Dispensary #2 of Krasnodar Region | |
| Sochi, Russian Federation, 354057 | |
| Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg | |
| St. Petersburg, Russian Federation, 197758 | |
| Yaroslavl Regional Clinical Oncology Hospital | |
| Yaroslavl, Russian Federation, 150054 | |
| South Africa | |
| The Oncology Centre Durban | |
| Durban, KZ-Natal, South Africa, 4091 | |
| Westridge Medical Centre | |
| Durban, KZ-Natal, South Africa, 4091 | |
| CANSA | |
| Polokwane, N Province, South Africa, 0699 | |
| Groote Schuur Hospital | |
| Cape Town, W Cape, South Africa, 7925 | |
| Netcare Oncology and Interventional Centre | |
| Goodwood, W Cape, South Africa, 7460 | |
| Pretoria Urology Hospital | |
| Pretoria, South Africa, 0083 | |
| Spain | |
| Hospital del Mar | |
| Barcelona, Spain, 08003 | |
| Institut Catala D'Oncologia | |
| Barcelona, Spain, 08907 | |
| Hospital Arnau de Vilanova | |
| Lerida, Spain, 25198 | |
| Hospital Univ 12 de Octubre | |
| Madrid, Spain, 28041 | |
| HCU Virgen de la Victoria | |
| Malaga, Spain, 29010 | |
| Clinica Universitaria de Navarra | |
| Pamplona, Spain, 31008 | |
| Hospital Mutua de Terrassa | |
| Terrassa, Spain, 08221 | |
| Hospital Clínico Universitario de Valencia | |
| Valencia, Spain, 46010 | |
| Hospital Universitario Miguel Servet | |
| Zaragoza, Spain, 50009 | |
| Sweden | |
| Laenssjukhuset Ryhov | |
| Joenkoeping, Sweden, 55185 | |
| Norrlands Universitetssjukhus | |
| Umea, Sweden, 90185 | |
| Centrallasarettet Vaesteras | |
| Vesteras, Sweden, 72189 | |
| United Kingdom | |
| Addenbrookes Hospital | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Royal Surrey County Hospital | |
| Guildford, United Kingdom, GU2 7XX | |
| Northern Lincolnshire & Goole Hospitals NHS Foundation Trust | |
| Hull, United Kingdom, HU16 5JQ | |
| Guy's and St Thomas' Hospital | |
| London, United Kingdom, SE1 9RT | |
| Royal Marsden Hospital | |
| London, United Kingdom, SW3 6JJ | |
| St George's Hospital | |
| London, United Kingdom, SW17 0QT | |
| Christie NHS Trust Hospital | |
| Manchester, United Kingdom, M20 4BX | |
| Nottingham University Hospital | |
| Nottingham, United Kingdom, NG5 1PB | |
| Royal Marsden Hospital | |
| Sutton, United Kingdom, SM2 5PT | |
| Clatterbridge Hospital | |
| Wirral, United Kingdom, CH63 4JY | |
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 |
| Last Updated: | September 27, 2012 |
| 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 Prednisone Docetaxel Lenalidomide Thalidomide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 13, 2013