Melanoma Clinical Trial
Official title:
A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
| Verified date | June 2012 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)
| Status | Completed |
| Enrollment | 655 |
| Est. completion date | August 2010 |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions. - Serum lactic acid dehydrogenase (LDH) <= 2 x ULN - ECOG performance status of 0 or 1 Exclusion Criteria: - Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma. - History of brain metastases |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Ciudad de Buenos Aires | Buenos Aires |
| Australia | Research Site | Adelaide | South Australia |
| Australia | Research Site | East Melbourne | Victoria |
| Australia | Research Site | Launceston | Tasmania |
| Australia | Research Site | Waratah | New South Wales |
| Australia | Research Site | Westmead | New South Wales |
| Australia | Research Site | Woolloongabba | Queensland |
| Austria | Research Site | Wien | |
| Belgium | Research Site | Brussel | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Namur | |
| Belgium | Research Site | Roeselare | |
| Belgium | Research Site | Turnhout | |
| Belgium | Research Site | Wilrijk | |
| Belgium | Research Site | Yvoir | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Victoria | British Columbia |
| Canada | Research Site | Windsor | Ontario |
| Canada | Research Site | Windsor | Ontario |
| Canada | Research Site | Winnipeg | Manitoba |
| France | Research Site | Besancon | |
| France | Research Site | Bordeaux | |
| France | Research Site | Boulogne | |
| France | Research Site | Caen | |
| France | Research Site | Lille | |
| France | Research Site | Marseille | |
| France | Research Site | Montpellier | Cedex 05 |
| France | Research Site | Nantes Cedex 1 | |
| France | Research Site | Paris | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Kiel | |
| Germany | Research Site | Tuebingen | |
| Greece | Research Site | Athens | |
| Israel | Research Site | Jerusalem | |
| Israel | Research Site | Tel Aviv | |
| Israel | Research Site | Tel Hashomer | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Padova | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Siena | |
| Mexico | Research Site | Mexico | DF |
| Mexico | Research Site | Mexico | DF |
| Netherlands | Research Site | Amsterdam | NH |
| Netherlands | Research Site | Groningen | GR |
| Netherlands | Research Site | Leiden | ZH |
| Netherlands | Research Site | Nijmegen | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lubin | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Warszawa | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Obninsk | Kaluga Region |
| Russian Federation | Research Site | St. Petersburg | |
| Slovakia | Research Site | Bratislava | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Pretoria | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Hospitalet de Llobregat | Barcelona |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Oviedo | Asturias |
| Spain | Research Site | Palma de Mallorca | Islas Baleares |
| Spain | Research Site | Pamplona | Navarra |
| Spain | Research Site | Santander | Cantabria |
| Spain | Research Site | Zaragoza | |
| Sweden | Research Site | Goteborg | |
| Sweden | Research Site | Lund | |
| Switzerland | Research Site | Zurich | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Newcastle upon Tyne | |
| United Kingdom | Research Site | Newcastle Upon Tyne | |
| United Kingdom | Research Site | Northwood | Middlesex |
| United Kingdom | Research Site | Sutton | Surrey |
| United Kingdom | Research Site | Truro | Cornwall |
| United Kingdom | Research Site | Wolverhampton | |
| United States | Research Site | Albany | New York |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Beech Grove | Indiana |
| United States | Research Site | Bethlehem | Pennsylvania |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Corona | California |
| United States | Research Site | Creve Coeur | Missouri |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dover | Ohio |
| United States | Research Site | Federal Way | Washington |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Glendora | California |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | Huntington Beach | California |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Lake Worth | Florida |
| United States | Research Site | Lakewood | Washington |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Alamitos | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Morristown | New Jersey |
| United States | Research Site | New York | New York |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Oxnard | California |
| United States | Research Site | Pasadena | California |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pomona | California |
| United States | Research Site | Rancho Cucamonga | California |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | Santa Barbara | California |
| United States | Research Site | Santa Maria | California |
| United States | Research Site | Scottsdale | Arizona |
| United States | Research Site | St Louis | Missouri |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | St. Peters | Missouri |
| United States | Research Site | Stamford | Connecticut |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | West Covina | California |
| United States | Research Site | Zion | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall survival | August 2010 | No | |
| Secondary | adverse events | 1 year | No | |
| Secondary | PFS at 6 months | 6 months | No | |
| Secondary | objective tumor response | 1 year | No | |
| Secondary | Durable response | 6 months | No | |
| Secondary | pharmacokinetics endpoints | 15 months | No | |
| Secondary | pharmacogenomic endpoints | 1 year | No | |
| Secondary | HQol | 1 year | No | |
| Secondary | healthcare resource utilization and loss of productivity | 1 year | No | |
| Secondary | human antihuman antibody response for patients in Arm A | 15 months | No |
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