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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Palbociclib will be administered orally at a dose of 125 mg/day, until disease progression, unacceptable adverse side effects or study end.
Hospital Insular de Canarias
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, Valencia, Spain
Hospital Clínic de Barcelona
Progression-free Survival (PFS) at Six Months (PFS6m)
Percentage of patients who have progressed / no progress after 6 months of treatment
Time frame: 6 months
Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.)
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.
Time frame: Three years
Anti-tumor Response According to RANO Criteria
According to RANO criteria, assessed by the PI of each center. There will be a central review.
Time frame: 30 months
Overall Survival (OS)
Time from randomization to death by any cause.
Time frame: With a median follow-up of 12 (0.9-52.2) months
Changes in the Use of Glucocorticoids
Percentage of patients decreasing doses of corticosteroids during treatment. Corticoids evolution
Time frame: 30 months
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Barcelona, Spain
ICO Hospitalet
Barcelona, Spain
Hospital de León
León, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Regional de Málaga
Málaga, Spain
Hospital Virgen del Rocio
Seville, Spain
...and 1 more locations