Phase II multicenter trial of palbociclib in second line of advanced sarcomas with CDK4 overexpression. - PalboSarc

Grupo Español de Investigación en Sarcomas (GEIS)0 sitesDecember 27, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 27, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Grupo Español de Investigación en Sarcomas (GEIS)

•1\)Over\-expression of CDK4 (mRNA expression) and a low\-to\-normal p16 expression (mRNA expression) measured in paraffin embedded tumor samples at study entry.
•2\)ECOG 0\-1 at enrollment.
•3\)Diagnosis of soft tissue sarcoma or osteosarcoma (in both cases with metastasis or locally advanced, unresectable).
•4\)Disease progression documented within 6 months prior to study entry.
•5\)Patients must have the following laboratory results:
•ANC \= 1,500/mm3 (1\.5 x 109/L);
•Platelets \= 100,000/mm3 (100 x 109/L);
•Hemoglobin \= 9 g/dL (90 g/L);
•Serum creatinine \= 1\.5 x ULN or estimated creatinine clearance \= 60 mL/min;
•Total serum bilirubin \= 1\.5 x ULN (\= 3\.0 x ULN if Gilbert’s disease);

•1\)Previous treatment with any anti CDK4 or immune checkpoint inhibitor.
•2\)Diagnosis of Ewing sarcoma or rhabdomyosarcoma.
•3\)Diagnosis of well differentiated/dedifferentiated liposarcoma.
•4\)Patients irradiated on the only target lesion available.
•5\)Patients having received more than two lines for advanced disease.
•6\)History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
•7\)Serious cardiovascular disease (NYHA \>\= 2\)
•8\)Grade 3 or superior toxicity according to CTCAE 4\.0 if the investigator considers this can significantly interfere in the toxicity of the drug under study.
•9\)Patients not recovered from a previous toxicity to at least CTCAE Grade 1 due to prior chemotherapy, radioactive, or biological cancer therapy (including monoclonal antibodies).
•10\)Patients not recovered from minor or major surgery or having undergone a major surgery within the last 4 weeks prior to initiation of study treatment.