Spots Global Cancer Trial Database for A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer
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Trial Identification
Brief Title: A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer
Official Title: A Phase 1b, Multicenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of CC-90011 Given in Combination With Cisplatin and Etoposide in First Line, Extensive Stage Subjects With Small Cell Lung Cancer
Study ID: NCT03850067
Conditions
Study Description
Brief Summary: CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects with first line ES SCLC. The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin, etoposide and/or carboplatin with or without Nivolumab (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with chemotherapy with or without Nivolumab to subjects with first line ES SCLC.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 102, Marseille Cedex 5, , France
Local Institution - 103, Saint-Herblain, , France
Local Institution - 100, Villejuif CEDEX, , France
Local Institution - 203, Ancona, , Italy
Local Institution - 200, Bologna, , Italy
Local Institution - 201, Rozzano (MI), , Italy
Local Institution - 403, Barcelona, , Spain
Local Institution - 402, Barcelona, , Spain
Local Institution - 400, Madrid, , Spain
Local Institution - 406, Majadahonda, Madrid, , Spain
Local Institution - 404, Malaga, , Spain
Local Institution - 405, Valencia, , Spain
Local Institution - 401, Valencia, , Spain
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Name: Oscar Juan Vidal, MD, PhD
Affiliation: Hospital Universitario La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: Stefania Salvagni, MD
Affiliation: Azienda Ospedaliero Universitarua, Policlinico S. Orsola Malpighi
Role: PRINCIPAL_INVESTIGATOR
Name: Rossana Berardi, MD
Affiliation: Ospedali Riuniti di Ancona
Role: PRINCIPAL_INVESTIGATOR
Name: Armando Santoro, MD
Affiliation: IRCCS Instituto Clinic Humanitas
Role: PRINCIPAL_INVESTIGATOR
Name: Benjamin Besse, MD, PhD
Affiliation: Gustave Roussy, Ditep
Role: PRINCIPAL_INVESTIGATOR
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