A Study of RO5185426 in Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01307397
First received: February 17, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

This open-label, multicenter study will evaluate the safety and efficacy of RO51 85426 in patients with BRAF V600 mutation-positive, surgically incurable and unr esectable stage IIIC or IV metastatic melanoma. Eligible patients will receive R O5185426 (960 mg twice daily orally) until disease progression or unacceptable t oxicity occurs, with a safety follow-up of 24 months after discontinuation of th e study drug.


Condition Intervention Phase
Malignant Melanoma
Drug: RO5185426
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response Rate, tumor assessments according to RECIST criteria [ Time Frame: 22 months ] [ Designated as safety issue: No ]

Enrollment: 3255
Study Start Date: March 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: RO5185426
960 mg twice daily orally

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 16 years of age
  • Histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
  • Patients may or may not have received prior systemic therapy for metastatic melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematologic, renal and liver function

Exclusion Criteria:

  • Evidence of symptomatic CNS lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426
  • Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
  • Concurrent administration of any anti-cancer therapies other than those administered in the study
  • Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
  • Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
  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: NCT01307397

  Hide Study Locations
Locations
Albania
Tirana, Albania, 1000
Argentina
Buenos Aires, Argentina, C1425DTG
Buenos Aires, Argentina, C1280AEB
Buenos Aires, Argentina, C1426ANZ
Australia, New South Wales
North Sydney, New South Wales, Australia, 2060
Waratah, New South Wales, Australia, 2298
Westmead, New South Wales, Australia, 2145
Wodonga, New South Wales, Australia, 3690
Australia, Queensland
Greenslopes, Queensland, Australia, 4120
Townsville, Queensland, Australia, 4812
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Geelong, Victoria, Australia, 3220
Melbourne, Victoria, Australia, 3002
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Austria
Feldkirch, Austria, 6807
Graz, Austria, 8036
Innsbruck, Austria, 6020
Linz, Austria, 4020
Salzburg, Austria, 5020
St. Pölten, Austria, 3100
Wien, Austria, 1090
Belgium
Brussel, Belgium, 1090
Bruxelles, Belgium, 1200
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Rio de Janeiro, RJ, Brazil, 20230-130
Porto Alegre, RS, Brazil, 90035-003
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 01509-010
Sao Paulo, SP, Brazil, 01321-001
Bulgaria
Plovdiv, Bulgaria, 4000
Sofia, Bulgaria, 1756
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
North Vancouver, British Columbia, Canada, V7L 2L7
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
London, Ontario, Canada, N6A 4L6
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2M9
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Quebec City, Quebec, Canada, G1R 2J6
Colombia
Bogota, Colombia
Cali, Colombia
Medellin-Antioquia, Colombia
Croatia
Zagreb, Croatia, 10000
Czech Republic
Brno, Czech Republic, 656 53
Hradec Kralove, Czech Republic, 500 05
Olomouc, Czech Republic, 775 20
Ostrava, Czech Republic, 708 52
Praha, Czech Republic
Praha, Czech Republic, 128 00
Denmark
Aarhus C, Denmark, 8000
Herlev, Denmark, 2730
Odense, Denmark, 5000
Ecuador
Cuenca, Ecuador
Guayaquil, Ecuador, EC090104
Portoviejo, Ecuador, EC130104
Estonia
Tallinn, Estonia, 13419
Tallinn, Estonia, 11312
Tartu, Estonia, 50406
Finland
Helsinki, Finland, 00029
Tampere, Finland, 33520
Turku, Finland, 20520
Germany
Aachen, Germany, 52074
Augsburg, Germany, 86179
Berlin, Germany, 12200
Bochum, Germany, 44791
Buxtehude, Germany, 21614
Chemnitz, Germany, 09117
Dresden, Germany, 01307
Düsseldorf, Germany, 40225
Erfurt, Germany, 99089
Erlangen, Germany, 91054
Essen, Germany, 45122
Frankfurt, Germany, 60596
Freiburg, Germany, 79104
Gera, Germany, 07548
Göttingen, Germany, 37075
Hamburg, Germany, 20246
Hannover, Germany, 30449
Heidelberg, Germany, 69115
Heilbronn, Germany, 74078
Jena, Germany, 07743
Kassel, Germany, 34125
Kiel, Germany, 24105
Köln, Germany, 50937
Leipzig, Germany, 04103
Ludwigshafen, Germany, 67063
Lübeck, Germany, 23538
Magdeburg, Germany, 39120
Mainz, Germany, 55131
Mannheim, Germany, 68167
Marburg, Germany, 35043
Minden, Germany, 32429
München, Germany, 80337
München, Germany, 80804
Münster, Germany, 48157
Münster, Germany, 48149
Nürnberg, Germany, 90419
Quedlinburg, Germany, 06484
Recklinghausen, Germany, 45657
Regensburg, Germany, 93053
Tübingen, Germany, 72076
Wiesbaden, Germany, 65191
Wuppertal, Germany, 42283
Würzburg, Germany, 97080
Greece
Athens, Greece, 115 27
Athens, Greece, 15123
Heraklion, Greece, 711 10
Piraeus, Greece, 18547
Hungary
Budapest, Hungary, 1085
Budapest, Hungary, 1122
Debrecen, Hungary, 4012
Pecs, Hungary, 7632
Szeged, Hungary, 6720
India
Hyderabad, India, 500034
Lucknow, India, 226003
Mumbai, India, 400012
Nashik, India, 422004
New Delhi, India, 110085
Trivandrum, India, 695 011
Vellore, India, 632004
Ireland
Cork, Ireland
Dublin, Ireland, 7
Dublin, Ireland, 4
Dublin, Ireland
Galway, Ireland
Limerick, Ireland
Waterford, Ireland
Israel
Beer Sheva, Israel, 8410101
Hafia, Israel, 3109601
Jerusalem, Israel, 91120-01
Ramat Gan, Israel, 52620-00
Italy
Napoli, Campania, Italy, 80131
Meldola, Emilia-Romagna, Italy, 47014
Modena, Emilia-Romagna, Italy, 41100
Reggio Emilia, Emilia-Romagna, Italy, 42100
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00167
Genova, Liguria, Italy, 16132
Bergamo, Lombardia, Italy, 24127
Brescia, Lombardia, Italy, 25123
Milano, Lombardia, Italy, 20133
Milano, Lombardia, Italy, 20141
Milano, Lombardia, Italy, 20132
Torino, Piemonte, Italy, 10126
Bari, Puglia, Italy, 70126
Palermo, Sicilia, Italy, 90127
Firenze, Toscana, Italy, 50139
Pisa, Toscana, Italy, 50126
Siena, Toscana, Italy, 53100
Terni, Umbria, Italy, 05100
Padova, Veneto, Italy, 35128
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 110-744
Latvia
Daugavpils, Latvia, 5417
Riga, Latvia, LV 1079
Lithuania
Klaipeda, Lithuania, 92288
Vilnius, Lithuania, 08661
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Leon, Mexico, 37000
Mexico City, Mexico, 14000
Mexico DF, Mexico, 06726
Netherlands
Amsterdam, Netherlands, 1081 HV
Amsterdam, Netherlands, 1066 CX
Blaricum, Netherlands, 1261 AN
Breda, Netherlands, 4818 CK
Groningen, Netherlands, 9713 GZ
Leiden, Netherlands, 2333 ZA
Maastricht, Netherlands, 6229 HX
Nijmegen, Netherlands, 6500 HB
Rotterdam, Netherlands, 3015 GD
Utrecht, Netherlands, 3584 CX
Norway
Bergen, Norway, 5021
Oslo, Norway, 0379
Peru
Arequipa, Peru, 04001
Lima, Peru, 34
Poland
Krakow, Poland, 31-531
Olsztyn, Poland, 10-228
Poznan, Poland, 60-693
Warszawa, Poland, 02-781
Portugal
Lisboa, Portugal, 1099-023
Porto, Portugal, 4200-072
Romania
Bucuresti, Romania, 022328
Cluj-Napoca, Romania, 400058
Timisoara, Romania, 300167
Russian Federation
Krasnodar, Russian Federation, 350040
Moscow, Russian Federation, 143423
Moscow, Russian Federation, 115478
Saint-Petersburg, Russian Federation, 197758
Saint-Petersburg, Russian Federation, 197022
Stavropol, Russian Federation, ND
UFA, Russian Federation, 450054
Serbia
Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Slovakia
Bratislava, Slovakia, 812 50
Bratislava, Slovakia, 833 10
Poprad, Slovakia, 058 01
Slovenia
Ljubljana, Slovenia, 1000
South Africa
Bloemfontein, South Africa, 9300
Cape Town, South Africa, 7570
Cape Town, South Africa, 7700
Johannesburg, South Africa, 2196
Pretoria, South Africa, 0002
Sandton, South Africa, 2196
Spain
Oviedo, Asturias, Spain, 33006
Santander, Cantabria, Spain, 39008
Palma De Mallorca, Islas Baleares, Spain, 07014
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Cartagena (Murcia), Murcia, Spain, 30202
Pamplona, Navarra, Spain, 31008
Vigo, Pontevedra, Spain, 36204
La Laguna (Tenerife), Tenerife, Spain, 38320
Barakaldo, Vizcaya, Spain, 48903
Barcelona, Spain, 08035
Barcelona, Spain, 08916
Barcelona, Spain, 08036
Cordoba, Spain, 14004
Granada, Spain, 18014
La Coruña, Spain, 15006
Leon, Spain, 24071
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Malaga, Spain, 29010
Salamanca, Spain, 37007
Sevilla, Spain, 41009
Valencia, Spain, 41014
Valencia, Spain, 46009
Zaragoza, Spain, 50009
Sweden
Goteborg, Sweden, 40036
Lund, Sweden, 22185
Stockholm, Sweden, 171 76
Umeå, Sweden
Uppsala, Sweden, 75185
Switzerland
Basel, Switzerland, 4031
Bern, Switzerland, 3010
Chur, Switzerland, 7000
Lausanne, Switzerland, 1011
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8091
Turkey
Adana, Turkey, 01120
Adana, Turkey, 01330
Ankara, Turkey, 06230
Ankara, Turkey, 06500
Antalya, Turkey, 07000
Bornova, ?ZM?R, Turkey, 35100
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34365
Istanbul, Turkey, 34300
Istanbul, Turkey, 34000
Izmir, Turkey, 35340
S?hhiye, ANKARA, Turkey, 06100
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
Glasgow, United Kingdom, G12 0YN
Guildford, United Kingdom, GU2 7XX
Leeds, United Kingdom, LS9 7TF
London, United Kingdom, SW3 6JJ
Manchester, United Kingdom, M20 4BX
Newcastle upon Tyne, United Kingdom, NE7 7DN
Northwood, United Kingdom, HA6 2RN
Nottingham, United Kingdom, NG5 1PB
Oxford, United Kingdom, OX3 7LJ
Southampton, United Kingdom, SO16 6YD
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01307397     History of Changes
Other Study ID Numbers: MO25515
Study First Received: February 17, 2011
Last Updated: August 11, 2014
Health Authority: Greece: Ministry of Health

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 11, 2014