Recurrent anaplasic oligodendroglioma or oligoastrocytome
Conditions
Interventions
Product Name: Palbociclib
Product Code: PD0332991
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Palbociclib
Other descriptive name: PALBOCICLIB
Concentration unit: mg milligram(s)
Concentrat
Sponsors
GRUPO ESPAÑOL DE INVESTIGACIÓN EN NEUROONCOLOGGÍA (GEINO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with anaplasic oligodendroglioma or oligoastrocytome histologically confirmed 2. Patients in relapse after radiotherapy and one or two lines of chemotherapy. 3. All patients have to present possitivity in immunohistochemical study for the RB protein in the tumor samples sent to the central lab. 4. The cases must have 10 slides or a tumor block available from a biopsy or cirurgy. 5. All patients have to show disease progression in a cerebral nuclear magnetic resonance. 6. Interval of at least one week between the previous intracranial biopsy and the inclusion. 7. Interval of at least 12 weeks between radiotherapy and the inclusion, unless: a) Recurrent tumor confirmed histologically b) recurrency showed in the NMR out of radiotherapy 8. Stable or decreasing dose of corticoids during the five days prior to the inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Presence of meningeal carcinomatosis disseminated 2. Concomitant treatment with other investigational products 3. Any kind of cirugy in the previous 2 weeks 4. Presence of any gastrointestinal alteration clinically significant 5. In the 7 days prior to the begining of the treatment, to have recived a treatment with: - Drugs inhibitor of the CYP3A4 - Durgs inductors of the CYP3A4 - Durgs that extends the QT interval 6. QTc interval >480 msec, familiar history or personal of QT large Syndrome, QT short Siyndrome, Brugada syndrome, QTc extension or Torsade de Pointes history 7. Electrolitic alteration that may afect to the QTc interval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the progression free survival at 6 months;Secondary Objective: To determine the safety and tolerability To determine the anti-tumoral response following the RANO criteria To assess the overall survival (OS) To assess the response duration in patients with objective response To assess changes in glucocorticoid use To assess change in neurological status To determine if some biomarkers have any relation with PFS and OS;Primary end point(s): Percentage of patients that have or not relapsed to the study treatment at 6 months after the begining of the treatment.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the safety and tolerability To determine the anti-tumoral response following the RANO criteria To assess the overall survival (OS) To assess the response duration in patients with objective response To assess changes in glucocorticoid use To assess change in neurological status To determine if some biomarkers have any relation with PFS and OS;Timepoint(s) of evaluation of this end point: Duration of the trial Duration of Response (DR) - duration of the trial Overall Survival (OR) - duration of the trial Safety - The safety period includes the time between the date of signing the informed consent until 28 days after the last dose of study drug | — |
Countries
Spain
Contacts
Public ContactMARKETING FARMACÉUTICO & INVESTIGAC
MARKETING FARMACÉUTICO & INVESTIGACIÓN CLÍNICA
Outcome results
None listed