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
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|ClinicalTrials.gov Identifier: NCT02530320|
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : April 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oligodendroglioma Oligoastrocytoma||Drug: Palbociclib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 25, 2015|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||March 2020|
Experimental: Palbociclib (PD0332991)
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.
Other Name: PD0332991
- Progression-free survival (PFS) at six months (PFS6m) [ Time Frame: 6 months ]Percentage of patients who have progressed / no progress after 6 months of treatment
- 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.) [ Time Frame: Three years ]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.
- Anti-tumor response according to RANO criteria [ Time Frame: 30 months ]According to RANO criteria, assessed by the PI of each center. There will be a central review.
- Overall survival (OS) [ Time Frame: 30 months ]Time from randomization to death by any cause.
- Response duration [ Time Frame: 30 months ]Time from first objective response up to disease progression according RANO (in patients with objective responses).
- Changes in the use of glucocorticoids [ Time Frame: 30 months ]Percentage of patients decreasing doses of corticosteroids during treatment.
- Changes in neurological status. [ Time Frame: 30 months ]By means of minimental test, it will be determined the changes in neurological status of patients.
- Tumor biomarkers assessment [ Time Frame: 30 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530320
|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|
|Castello de la Plana, Valencia, Spain|
|Hospital Clínic de Barcelona|
|Hospital de León|
|Hospital 12 de Octubre|
|Hospital Ramón y Cajal|
|Hospital Regional de Málaga|
|Hospital Virgen del Rocio|
|Hospital Universitario y Politécnico La Fe|
|Principal Investigator:||Juan Manuel Sepúlveda||H. 12 de Octubre|