At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
Palbociclibdrug
Likely dose
Palbociclib 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Grupo Español de Investigación en Neurooncología·interventional·Posted Aug 21, 2015·Updated Nov 22, 2024
In Brief
A Phase 2 clinical trial evaluating Palbociclib for Oligodendroglioma and Oligoastrocytoma. Completed, enrolled 34 participants across 11 sites.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOligodendroglioma, Oligoastrocytoma
CountriesSpain
CollaboratorsPfizer
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartOct 2015
Primary CompletionDec 2019
Study CompletionMar 2020
TodayJul 2026
First PostedAug 21, 2015
Enrollment StartOct 25, 2015
Primary CompletionDec 1, 2019
Study CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.9 years ago
Interventions
Palbociclibdrug
Palbociclib will be administered orally at a dose of 125 mg/day, until disease progression, unacceptable adverse side effects or study end.