Spots Global Cancer Trial Database for Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.
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Trial Identification
Brief Title: Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.
Official Title: Phase II Multicenter Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.
Study ID: NCT03242382
Interventions
Study Description
Brief Summary: Non-randomized, open, two-cohort, phase II, multicenter national clinical trial. 20 sites in Spain. Cohort 1 includes soft-tissue sarcoma and osteosarcoma (21 patients), while Cohort 2 includes chordoma patients only (19 patients). Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive days followed by 7 rest days to comprise a complete cycle of 28 days. Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision. The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1 at 6 months.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain
Institut Català d'Oncología l'Hospitalet, Barcelona, , Spain
Complejo Asistencial Universitario de León, León, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Fundación Jimenez Diaz, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitari Son Espases, Palma De Mallorca, , Spain
Hospital Universitario de Canarias, Santa Cruz De Tenerife, , Spain
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Irene Carrasco García, MD
Affiliation: Hospitales Universitarios Virgen del Rocío
Role: STUDY_DIRECTOR
Name: Roberto Díaz, MD
Affiliation: Hospital Universitario La Fe
Role: STUDY_DIRECTOR
Name: Javier Martínez Trufero, MD
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: Yolanda Vidal, MD
Affiliation: Complejo Hospitalario Universitario de Santiago
Role: PRINCIPAL_INVESTIGATOR
Name: Juan Luís García Llano, MD
Affiliation: Hospital Universitario Central de Asturias
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio López-Pousa, MD
Affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Role: PRINCIPAL_INVESTIGATOR
Name: Diego Jara, MD
Affiliation: Hospital Universitario 12 de Octubre
Role: PRINCIPAL_INVESTIGATOR
Name: Isabel Sevilla, MD
Affiliation: Hospital Universitario Virgen de la Victoria
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Martín Broto
Affiliation: Hospital Universitario Fundación Jiménez Díaz
Role: PRINCIPAL_INVESTIGATOR
Name: Anna Estival
Affiliation: Germans Trias i Pujol Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Luís Miguel de Sande
Affiliation: Complejo Asistencial Universitario de León
Role: PRINCIPAL_INVESTIGATOR
Name: Rosa Álvarez
Affiliation: Hospital General Universitario Gregorio Marañón
Role: PRINCIPAL_INVESTIGATOR
Name: Claudia Valverde
Affiliation: Hospital Universitari Vall d'Hebrón
Role: PRINCIPAL_INVESTIGATOR
Name: Andrés Redondo
Affiliation: Hospital Universitario La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: Josefina Cruz
Affiliation: Hospital Universitario de Canarias
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Lavernia
Affiliation: Instituto Valenciano de Oncología
Role: PRINCIPAL_INVESTIGATOR
Name: Pablo Luna
Affiliation: Hospital Son Espases
Role: PRINCIPAL_INVESTIGATOR
Name: Jerónimo Martínez
Affiliation: Hospital Clínico Universitario Virgen de la Arrixaca
Role: PRINCIPAL_INVESTIGATOR
Name: Xavier García del Muro
Affiliation: Institut Català d'Oncología l'Hospitalet
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Casado
Affiliation: Hospital San Carlos, Madrid
Role: PRINCIPAL_INVESTIGATOR
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