NCT03242382

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Grupo Espanol de Investigacion en Sarcomas · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2017-03-31
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2017-08-08
• Last updated: 2024-01-23

Locations

19 sites across 1 country: Spain