Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.

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.

Conditions

• Soft-tissue Sarcoma
• Osteosarcoma
• Chordoma

Interventions

DRUG

Palbociclib

Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision

Sponsors & Collaborators

• Grupo Espanol de Investigacion en Sarcomas

  lead OTHER

Principal Investigators

• Irene Carrasco García, MD · Hospitales Universitarios Virgen del Rocío

• Roberto Díaz, MD · Hospital Universitario La Fe

• Javier Martínez Trufero, MD · Hospital Miguel Servet

• Yolanda Vidal, MD · Complejo Hospitalario Universitario de Santiago

• Juan Luís García Llano, MD · Hospital Universitario Central de Asturias

• Antonio López-Pousa, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Diego Jara, MD · Hospital Universitario 12 de Octubre

• Isabel Sevilla, MD · Hospital Universitario Virgen de la Victoria

• Javier Martín Broto · Hospital Universitario Fundación Jiménez Díaz

• Anna Estival · Germans Trias i Pujol Hospital

• Luís Miguel de Sande · Complejo Asistencial Universitario de León

• Rosa Álvarez · Hospital General Universitario Gregorio Marañón

• Claudia Valverde · Hospital Universitari Vall d'Hebrón

• Andrés Redondo · Hospital Universitario La Paz

• Josefina Cruz · Hospital Universitario de Canarias

• Javier Lavernia · Instituto Valenciano de Oncología

• Pablo Luna · Hospital Son Espases

• Jerónimo Martínez · Hospital Universitario Virgen de la Arrixaca

• Xavier García del Muro · Institut Català d'Oncología l'Hospitalet

• Antonio Casado · Hospital San Carlos, Madrid

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-31

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• Spain

Study Locations