Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.
- Registration Number
- NCT03242382
- Lead Sponsor
- Grupo Espanol de Investigacion en Sarcomas
- 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Palbocilib Palbociclib 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.
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) rate At 6 months Efficacy measured through the progression free survival (PFS) rate at 6 months, evaluated with RECIST 1.1 criteria.
- Secondary Outcome Measures
Name Time Method Efficacy measured through median PFS 6 months Efficacy measured through median PFS.
Overall response rate (ORR) 6 months Efficacy measured through the overall response rate (ORR) (complete response \[CR\] and partial response \[PR\]), evaluated with RECIST 1.1 criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
Efficacy measured through response according to Choi criteria measured through response according to Choi criteria: 6 months Efficacy measured through response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
Overall survival (OS) 2 years Overall survival (OS) measured from the date of treatment initiation with palbociclib until date of death, whichever the cause.
Clinical Benefit Rate (CBR) 6 months Clinical Benefit Rate (CBR). Patients having shown complete response, partial response, or disease stabilization during 6 months or more, showing clinical improvement symptoms, will be considered as having experienced clinical benefit.
Palbociclib safety profile 1 year Palbociclib safety profile, through the evaluation of adverse events (type, incidence, severity, timing of appearance, related causes) observed in physical explorations and laboratory tests. Toxicity will be assessed and tabulated using NCI-CTCAE 4.0 (first cohort; STS and osteosarcoma) and 5.0 (second cohort; chordomas).
Efficacy measured through PFS rate at 3 months 3 months Efficacy measured through PFS rate at 3 months.
Trial Locations
- Locations (19)
Hospital de la Santa Creu i Sant Pau
馃嚜馃嚫Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
馃嚜馃嚫Barcelona, Spain
Institut Catal脿 d'Oncolog铆a l'Hospitalet
馃嚜馃嚫Barcelona, Spain
Complejo Asistencial Universitario de Le贸n
馃嚜馃嚫Le贸n, Spain
Hospital Universitario Fundaci贸n Jimenez Diaz
馃嚜馃嚫Madrid, Spain
Hospital Cl铆nico Universitario Virgen de la Arrixaca
馃嚜馃嚫Murcia, Spain
Hospital Universitario Virgen de la Victoria
馃嚜馃嚫M谩laga, Spain
Hospital Universitario Central de Asturias
馃嚜馃嚫Oviedo, Spain
Hospital Universitario Virgen del Roc铆o
馃嚜馃嚫Sevilla, Spain
Hospital Universitari Son Espases
馃嚜馃嚫Palma De Mallorca, Spain
Hospital Universitario de Canarias
馃嚜馃嚫Santa Cruz De Tenerife, Spain
Complejo Hospitalario Universitario de Santiago
馃嚜馃嚫Santiago de Compostela, Spain
Hospital Universitari i Polit猫cnic La Fe
馃嚜馃嚫Valencia, Spain
Hospital Universitario Miguel Servet
馃嚜馃嚫Zaragoza, Spain
Instituto Valenciano de Oncolog铆a
馃嚜馃嚫Valencia, Spain
Hospital Cl铆nico San Carlos
馃嚜馃嚫Madrid, Spain
Hospital General Universitario Gregorio Mara帽on
馃嚜馃嚫Madrid, Spain
Hospital Universitario 12 de Octubre
馃嚜馃嚫Madrid, Spain
Hospital Universitario La Paz
馃嚜馃嚫Madrid, Spain