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 Neurooncología11 sites in 1 country34 target enrollmentOctober 25, 2015

ConditionsOligodendroglioma Oligoastrocytoma

InterventionsPalbociclib

DrugsPalbociclib

Overview

Phase: Phase 2
Intervention: Palbociclib
Conditions: Oligodendroglioma
Sponsor: Grupo Español de Investigación en Neurooncología
Enrollment: 34
Locations: 11
Primary Endpoint: Progression-free Survival (PFS) at Six Months (PFS6m)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 25, 2015

End Date

March 2020

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Grupo Español de Investigación en Neurooncología

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand and sign the informed consent approved by the Ethic Committee.
•Men or women aged greater than or equal to
•Patients with oligodendroglioma anaplastic or oligoastrocytoma anaplastic according to WHO classification and histologically confirmed. Note: It can be included patients with oligoastrocytoma or oligodendroglioma G2 only if they have suffered a recurrence in which the diagnosis of the resection were G
•Patients in relapse after radiotherapy and one or two lines of chemotherapy. Note: Both previous radiotherapy and chemotherapy could be received in adjuvant therapy or previous recurrences. It is also accepted to be received concurrent chemoradiotherapy. In the secondary oligodendrogliomas or oligoastrocytomas anaplastic, the patients could have received chemotherapy and radiotherapy when the tumor was G
•All patients have to present positivity in immunohistochemical study for the RB protein in the tumor samples sent to the central lab.
•The cases must have 10 slides or a tumor block available from a biopsy or surgery.
•All patients have to show disease progression in a cerebral nuclear magnetic resonance.
•Interval of at least one week between the previous intracranial biopsy and the inclusion.
•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.
•Patients should have been recovered from previous therapies: 28 days since the end of any investigational product and since the end of any cytotoxic treatment.

Exclusion Criteria

•Presence of meningeal carcinomatosis disseminated.
•Concomitant treatment with other investigational products
•Previous treatment wih an investigational product that could be active for CDK4/6
•Any kind of surgery in the previous 2 weeks
•Presence of any clinically significant gastrointestinal abnormality that can affect oral administration, transit or absorption of study drug, such as the inability to take medication by mouth as tablets.
•Presence of any psychiatric or cognitive disorder that limits the understanding or the signature of informed consent and / or jeopardize the fulfillment of the requirements of this protocol.
•In the 7 days prior to the beginning of the treatment, to have received a treatment with: - Drugs inhibitor of the CYP3A4 - Drugs inductors of the CYP3A4 - Drugs that extends the QT interval
•QTc interval \>480 msec, familiar history or personal of QT large Syndrome, QT short Syndrome, Brugada syndrome, QTc extension or Torsade de Pointes history
•Electrolyte disorder that may affect the QTc interval
•Significant or uncontrolled cardiovascular disease, including:

Arms & Interventions

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.

Intervention: Palbociclib

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.)(Three years)
Anti-tumor Response According to RANO Criteria(30 months)
Overall Survival (OS)(With a median follow-up of 12 (0.9-52.2) months)
Changes in the Use of Glucocorticoids(30 months)