Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 <

Brief 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.

Detailed Summary:
Sponsor: Grupo Español de Investigación en Neurooncología

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Grupo Español de Investigación en Neurooncología

Dates:
Date Received: August 18, 2015
Date Started: July 2015
Date Completion: December 2018
Last Updated: August 10, 2016
Last Verified: August 2016