Spots Global Cancer Trial Database for A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]
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Trial Identification
Brief Title: A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]
Official Title: A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)
Study ID: NCT01714037
Conditions
Study Description
Brief Summary: Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.
Detailed Description: Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC. Escalating doses of Debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre GF Leclerc, Dijon, , France
Centre Léon Bérard, Lyon, , France
Institut de Cancérologie de l'Ouest- Institut René Gauduchau, Nantes, , France
Institut Claudius Regaud, Toulouse, , France
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Puerta de Hierro Majadahonda, Madrid, , Spain
Hospital Universitario Virgen del Rocío, Seville, , Spain
Freeman Hospital, Newcastle, , United Kingdom
Contact Details
Name: Nicolas Isambert, MD
Affiliation: Centre GF Leclerc, Dijon, France
Role: PRINCIPAL_INVESTIGATOR
Name: Jean-Pierre Delord, PR
Affiliation: Institut Claudius Regaud, Toulouse, France
Role: PRINCIPAL_INVESTIGATOR
Name: Jèrôme Fayette, MD
Affiliation: Centre Léon Bérard, Lyon, France
Role: PRINCIPAL_INVESTIGATOR
Name: Jaafar Bennouma, MD
Affiliation: Institut de Cancérologie de l'Ouest- Institut René Gauduchau, Nantes, France
Role: PRINCIPAL_INVESTIGATOR
Name: Luis Paz-Ares, PR
Affiliation: Hospital Universitario Virgen del Rocío, Seville, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Enriqueta Felip, PR
Affiliation: Hospital Universitari Vall d'Hebron, Barcelone, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Mariano Provencio, PR
Affiliation: Hospital Puerta de Hierro Majadahonda, Madrid, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Ruth Plummer, PR
Affiliation: Freeman Hospital, Newcastle, UK
Role: PRINCIPAL_INVESTIGATOR
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