Ignite Creation Date:
2024-05-06 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03242382
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2017-08-03
Brief Title:
Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression
Sponsor:
Grupo Espanol de Investigacion en Sarcomas
Organization:
Grupo Espanol de Investigacion en Sarcomas
Study Overview
Official Title:
Phase II Multicenter Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PalboSarc
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 11 at 6 months
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 11 at 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None