Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Oligodendroglioma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Oligoastrocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Palbociclib

Protein Kinase Inhibitors

Enzyme Inhibitors

Palbociclib will be administrated orally at a dose of 125 mg/day during 21 days followed by a break of 7 days. All patients included will be treated in the same arm. Treatment will be administrated until disease progression, unacceptable adverse side effects or study end.

Palbociclib will be administered orally at a dose of 125 mg/day, until disease progression, unacceptable adverse side effects or study end.

Juan Manuel Sepúlveda

This multicenter, open-label, phase II trial aims to assess the safety and efficacy of palbociclib in adult patients with Oligodendroglioma or recurrent oligoastrocytoma anaplastic with the activity of the protein RB preserved.

Safety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved

Phase II Pilot, Prospective, Open Label, Multicenter CT, to Evaluate the Safety and Efficacy of Palbociclib (PD0332991), a Cyclin-dependent Kinase 4 and 6 (CDK4 and CDK6) Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved

Percentage of patients who have progressed / no progress after 6 months of treatment

Type, incidence, severity, frequency, severity and relationship with IMP of reported adverse events, physical examinations and laboratory tests. Toxicity will be classified and tabulated by NCI-CTCAE v 4.0.

According to RANO criteria, assessed by the PI of each center. There will be a central review.

Time from randomization to death by any cause.

Time from first objective response up to disease progression according RANO (in patients with objective responses).

Percentage of patients decreasing doses of corticosteroids during treatment.

By means of minimental test, it will be determined the changes in neurological status of patients.

It will be evaluated whether some biomarkers are related with the Progression Free Survival/Overall survival and response rates. The following biomarkers will be assessed: Deletions in CDKN2A, CDKN2B, 1p, 19q; mutations in IDH, amplifications in CDK4, CDK6, cyclin D.

Spots Global Cancer Trial Database for oligoastrocytoma anaplastic