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A Study of RO5185426 in Patients With Metastatic Melanoma

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Melanoma

Intervention: RO5185426 (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up of 24 months after discontinuation of the study drug.

Clinical Details

Official title: An Open-label, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety: Incidence of adverse events

Secondary outcome: Overall Response Rate, tumor assessments according to RECIST criteria

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Tirana 1000, Albania

Buenos Aires C1280AEB, Argentina

Buenos Aires C1425DTG, Argentina

Buenos Aires C1426ANZ, Argentina

Feldkirch 6807, Austria

Graz 8036, Austria

Innsbruck 6020, Austria

Linz 4020, Austria

Salzburg 5020, Austria

St. Pölten 3100, Austria

Wien 1090, Austria

Brussel 1090, Belgium

Bruxelles 1200, Belgium

Wilrijk 2610, Belgium

Banja Luka 78000, Bosnia and Herzegovina

Sarajevo 71000, Bosnia and Herzegovina

Plovdiv 4000, Bulgaria

Sofia 1756, Bulgaria

Bogota, Colombia

Cali, Colombia

Medellin-Antioquia, Colombia

Zagreb 10000, Croatia

Brno 656 53, Czech Republic

Hradec Kralove 500 05, Czech Republic

Olomouc 775 20, Czech Republic

Ostrava 708 52, Czech Republic

Praha, Czech Republic

Praha 128 00, Czech Republic

Aarhus C 8000, Denmark

Herlev 2730, Denmark

Odense 5000, Denmark

Cuenca, Ecuador

Guayaquil EC090104, Ecuador

Portoviejo EC130104, Ecuador

Tallinn 13419, Estonia

Tallinn 11312, Estonia

Tartu 50406, Estonia

Helsinki 00029, Finland

Tampere 33520, Finland

Turku 20520, Finland

Aachen 52074, Germany

Augsburg 86179, Germany

Berlin 12200, Germany

Bochum 44791, Germany

Buxtehude 21614, Germany

Chemnitz 09117, Germany

Dresden 01307, Germany

Düsseldorf 40225, Germany

Erfurt 99089, Germany

Erlangen 91054, Germany

Essen 45122, Germany

Frankfurt 60596, Germany

Freiburg 79104, Germany

Gera 07548, Germany

Göttingen 37075, Germany

Hamburg 20246, Germany

Hannover 30449, Germany

Heidelberg 69115, Germany

Heilbronn 74078, Germany

Jena 07743, Germany

Kassel 34125, Germany

Kiel 24105, Germany

Köln 50937, Germany

Leipzig 04103, Germany

Ludwigshafen 67063, Germany

Lübeck 23538, Germany

Magdeburg 39120, Germany

Mainz 55131, Germany

Mannheim 68167, Germany

Marburg 35043, Germany

Minden 32429, Germany

München 80337, Germany

München 80804, Germany

Münster 48149, Germany

Münster 48157, Germany

Nürnberg 90419, Germany

Quedlinburg 06484, Germany

Recklinghausen 45657, Germany

Regensburg 93053, Germany

Tübingen 72076, Germany

Wiesbaden 65191, Germany

Wuppertal 42283, Germany

Würzburg 97080, Germany

Athens 115 27, Greece

Athens 15123, Greece

Heraklion, Crete 71110, Greece

Piraeus 18547, Greece

Budapest 1122, Hungary

Budapest 1085, Hungary

Debrecen 4012, Hungary

Pecs 7632, Hungary

Szeged 6720, Hungary

Hyderabad 500034, India

Lucknow 226003, India

Mumbai 400012, India

Nashik 422004, India

New Delhi 110085, India

Trivandrum 695 011, India

Vellore 632004, India

Cork, Ireland

Dublin 7, Ireland

Dublin, Ireland

Dublin 4, Ireland

Galway, Ireland

Limerick, Ireland

Waterford, Ireland

Beer Sheva 8410101, Israel

Hafia 3109601, Israel

Jerusalem 91120-01, Israel

Ramat Gan 5262100, Israel

Seoul 110-744, Korea, Republic of

Seoul 120-752, Korea, Republic of

Seoul 135-710, Korea, Republic of

Seoul 137-701, Korea, Republic of

Seoul 138-736, Korea, Republic of

Daugavpils 5417, Latvia

Riga LV 1079, Latvia

Klaipeda 92288, Lithuania

Vilnius 08661, Lithuania

Skopje 1000, Macedonia, The Former Yugoslav Republic of

Leon 37000, Mexico

Mexico City 14000, Mexico

Mexico DF 06726, Mexico

Amsterdam 1081 HV, Netherlands

Amsterdam 1066 CX, Netherlands

Blaricum 1261 AN, Netherlands

Breda 4818 CK, Netherlands

Groningen 9713 GZ, Netherlands

Leiden 2333 ZA, Netherlands

Maastricht 6229 HX, Netherlands

Nijmegen 6500 HB, Netherlands

Rotterdam 3000 CA, Netherlands

Utrecht 3584 CX, Netherlands

Bergen 5021, Norway

Oslo 0379, Norway

Arequipa 04001, Peru

Lima 34, Peru

Krakow 31-531, Poland

Olsztyn 10-228, Poland

Poznań 60-693, Poland

Warszawa 02-781, Poland

Lisboa 1099-023, Portugal

Porto 4200-072, Portugal

Bucuresti 022328, Romania

Cluj-Napoca 400058, Romania

Timisoara 300167, Romania

Krasnodar 350040, Russian Federation

Moscow 115478, Russian Federation

Moscow 143423, Russian Federation

Saint-Petersburg 197022, Russian Federation

Saint-Petersburg 197758, Russian Federation

Stavropol ND, Russian Federation

UFA 450054, Russian Federation

Belgrade 11000, Serbia

Belgrade 11080, Serbia

Bratislava 812 50, Slovakia

Bratislava 833 10, Slovakia

Poprad 058 01, Slovakia

Ljubljana 1000, Slovenia

Bloemfontein 9300, South Africa

Cape Town 7570, South Africa

Cape Town 7700, South Africa

Johannesburg 2196, South Africa

Pretoria 0002, South Africa

Sandton 2196, South Africa

Barcelona 08035, Spain

Barcelona 08036, Spain

Barcelona 08916, Spain

Cordoba 14004, Spain

Granada 18014, Spain

La Coruña 15006, Spain

Leon 24071, Spain

Madrid 28034, Spain

Madrid 28040, Spain

Madrid 28041, Spain

Madrid 28046, Spain

Malaga 29010, Spain

Salamanca 37007, Spain

Sevilla 41009, Spain

Valencia 41014, Spain

Valencia 46009, Spain

Zaragoza 50009, Spain

Goteborg 40036, Sweden

Lund 22185, Sweden

Stockholm 171 76, Sweden

Umeå, Sweden

Uppsala 75185, Sweden

Basel 4031, Switzerland

Bern 3010, Switzerland

Chur 7000, Switzerland

Lausanne 1011, Switzerland

St. Gallen 9007, Switzerland

Zürich 8091, Switzerland

Adana 01120, Turkey

Adana 01330, Turkey

Ankara 06230, Turkey

Ankara 06500, Turkey

Antalya 07000, Turkey

Bornova, İZMİR 35100, Turkey

Gaziantep 27310, Turkey

Istanbul 34000, Turkey

Istanbul 34300, Turkey

Istanbul 34365, Turkey

Izmir 35340, Turkey

Sıhhiye, ANKARA 06100, Turkey

Cambridge CB2 2QQ, United Kingdom

Glasgow G12 0YN, United Kingdom

Guildford GU2 7XX, United Kingdom

Leeds LS9 7TF, United Kingdom

London SW3 6JJ, United Kingdom

Manchester M20 4BX, United Kingdom

Newcastle upon Tyne NE7 7DN, United Kingdom

Northwood HA6 2RN, United Kingdom

Nottingham NG5 1PB, United Kingdom

Oxford OX3 7LJ, United Kingdom

Southampton SO16 6YD, United Kingdom

Swansea SA2 8QA, United Kingdom

Edmonton, Alberta T6G 1Z2, Canada

Oviedo, Asturias 33011, Spain

North Vancouver, British Columbia V7L 2L7, Canada

Vancouver, British Columbia V5Z 4E6, Canada

Napoli, Campania 80131, Italy

Santander, Cantabria 39008, Spain

Meldola, Emilia-Romagna 47014, Italy

Modena, Emilia-Romagna 41100, Italy

Reggio Emilia, Emilia-Romagna 42100, Italy

Udine, Friuli-Venezia Giulia 33100, Italy

Palma De Mallorca, Islas Baleares 07014, Spain

Las Palmas de Gran Canaria, Las Palmas 35016, Spain

Roma, Lazio 00167, Italy

Roma, Lazio 00168, Italy

Genova, Liguria 16132, Italy

Bergamo, Lombardia 24127, Italy

Brescia, Lombardia 25123, Italy

Milano, Lombardia 20132, Italy

Milano, Lombardia 20133, Italy

Milano, Lombardia 20141, Italy

Winnipeg, Manitoba R2H 2A6, Canada

Cartagena (Murcia), Murcia 30202, Spain

Pamplona, Navarra 31008, Spain

North Sydney, New South Wales 2060, Australia

Waratah, New South Wales 2298, Australia

Westmead, New South Wales 2145, Australia

Wodonga, New South Wales 3690, Australia

Halifax, Nova Scotia B3H 1V7, Canada

Hamilton, Ontario L8V 5C2, Canada

London, Ontario N6A 4L6, Canada

Ottawa, Ontario K1H 8L6, Canada

Toronto, Ontario M4N 3M5, Canada

Toronto, Ontario M5G 2M9, Canada

Torino, Piemonte 10126, Italy

Vigo, Pontevedra 36312, Spain

Bari, Puglia 70126, Italy

Montreal, Quebec H3T 1E2, Canada

Quebec City, Quebec G1R 2J6, Canada

Greenslopes, Queensland 4120, Australia

Townsville, Queensland 4812, Australia

Woolloongabba, Queensland 4102, Australia

Rio de Janeiro, RJ 20230-130, Brazil

Porto Alegre, RS 90035-003, Brazil

Sao Paulo, SP 01246-000, Brazil

Sao Paulo, SP 01321-001, Brazil

Sao Paulo, SP 01509-010, Brazil

Palermo, Sicilia 90127, Italy

Adelaide, South Australia 5000, Australia

La Laguna (Tenerife), Tenerife 38320, Spain

Firenze, Toscana 50139, Italy

Pisa, Toscana 50126, Italy

Siena, Toscana 53100, Italy

Terni, Umbria 05100, Italy

Padova, Veneto 35128, Italy

Geelong, Victoria 3220, Australia

Melbourne, Victoria 3002, Australia

Melbourne, Victoria 3004, Australia

Barakaldo, Vizcaya 48903, Spain

Nedlands, Western Australia 6009, Australia

Additional Information

Starting date: March 2011
Last updated: August 17, 2015

Page last updated: August 20, 2015

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