Spots Global Cancer Trial Database for Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
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Trial Identification
Brief Title: Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
Official Title: Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy
Study ID: NCT01500720
Conditions
Study Description
Brief Summary: Primary Objective: To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy. Secondary Objectives: * To assess disease progression free rate at 12 weeks * To assess Response Rate (Response Evaluation Criteria in Solid Tumor \[RECIST\] 1.1) and duration of response * To assess Overall Survival (OS) * To assess the Safety (National Cancer Institute - Common Toxicity Criteria \[NCI-CTC\] version 4.03) * To assess the Health-Related Quality of Life (HRQoL)
Detailed Description: Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment. All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 840007, Muscle Shoals, Alabama, United States
Investigational Site Number 840005, Omaha, Nebraska, United States
Investigational Site Number 840006, Lebanon, New Hampshire, United States
Investigational Site Number 840003, Middletown, Ohio, United States
Investigational Site Number 840001, Philadelphia, Pennsylvania, United States
Investigational Site Number 076001, Porto Alegre, , Brazil
Investigational Site Number 124003, Montreal, , Canada
Investigational Site Number 124002, Oshawa, , Canada
Investigational Site Number 124004, Rimouski, , Canada
Investigational Site Number 124001, Toronto, , Canada
Investigational Site Number 152001, Santiago, , Chile
Investigational Site Number 152005, Santiago, , Chile
Investigational Site Number 250005, Brest, , France
Investigational Site Number 250004, Caen Cedex, , France
Investigational Site Number 250006, La Tronche, , France
Investigational Site Number 250002, Lille, , France
Investigational Site Number 250003, Saint-Herblain Cedex, , France
Investigational Site Number 250007, Villejuif Cedex, , France
Investigational Site Number 276003, Großhansdorf, , Germany
Investigational Site Number 276006, Löwenstein, , Germany
Investigational Site Number 300005, Athens, , Greece
Investigational Site Number 300003, Athens, , Greece
Investigational Site Number 300001, Heraklion, , Greece
Investigational Site Number 300002, Thessaloniki, , Greece
Investigational Site Number 300004, Thessaloniki, , Greece
Investigational Site Number 348001, Budapest, , Hungary
Investigational Site Number 348004, Budapest, , Hungary
Investigational Site Number 348002, Budapest, , Hungary
Investigational Site Number 348003, Törökbálint, , Hungary
Investigational Site Number 380001, Genova, , Italy
Investigational Site Number 380002, Livorno, , Italy
Investigational Site Number 380005, Novara, , Italy
Investigational Site Number 380004, Parma, , Italy
Investigational Site Number 410001, Seoul, , Korea, Republic of
Investigational Site Number 410003, Seoul, , Korea, Republic of
Investigational Site Number 410002, Seoul, , Korea, Republic of
Investigational Site Number 578001, Oslo, , Norway
Investigational Site Number 578003, Stavanger, , Norway
Investigational Site Number 578002, Trondheim, , Norway
Investigational Site Number 616004, Gdansk, , Poland
Investigational Site Number 616003, Lublin, , Poland
Investigational Site Number 616002, Poznan, , Poland
Investigational Site Number 616001, Warszawa, , Poland
Investigational Site Number 642003, Cluj Napoca, , Romania
Investigational Site Number 642005, Cluj-Napoca, , Romania
Investigational Site Number 642001, Craiova, , Romania
Investigational Site Number 642002, Timisoara, , Romania
Investigational Site Number 643001, Moscow, , Russian Federation
Investigational Site Number 643005, St-Petersburg, , Russian Federation
Investigational Site Number 643006, Tula, , Russian Federation
Investigational Site Number 643003, Yaroslavl, , Russian Federation
Investigational Site Number 724002, Badalona, , Spain
Investigational Site Number 724004, Barcelona, , Spain
Investigational Site Number 724005, Málaga, , Spain
Investigational Site Number 724001, Valencia, , Spain
Investigational Site Number 804002, Dnipropetrovsk, , Ukraine
Investigational Site Number 804004, Donetsk, , Ukraine
Investigational Site Number 804001, Lviv, , Ukraine
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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