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

NCT02530320 | Completed Phase 2 Results

• 1 other identifier: GEINO 13
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 11

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.

Conditions

Oligodendroglioma; Oligoastrocytoma

Keywords

Palbociclib; oligodendroglioma; oligoastrocytoma anaplastic

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) at Six Months (PFS6m)

  Percentage of patients who have progressed / no progress after 6 months of treatment

  6 months

Secondary Outcomes (4)

• 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

Study Arms (1)

Palbociclib (PD0332991)

EXPERIMENTAL

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.

Drug: Palbociclib

Interventions

Palbociclib DRUG

Palbociclib will be administered orally at a dose of 125 mg/day, until disease progression, unacceptable adverse side effects or study end.

Also known as: PD0332991

Palbociclib (PD0332991)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and sign the informed consent approved by the Ethic Committee.
• Men or women aged greater than or equal to 18.
• 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 G3.
• 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 G2.
• 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.
• 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.
• ECOG≤2
• patients who have been suffered from a tumor resection in the last recurrence are eligible if:
• A good surgery recover
• there is a measurable or evaluable disease after surgery
• Good bone marrow function:
• Neutrophils ≥ 1500/mm3 (1.5x10e9/L)
• Platelet ≥ 100.000/mm3 (100 x 10e9)

You may not qualify if:

• 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:
• Myocardial infarction within the previous 12 months
• Uncontrolled angina within the previous 6 months
• Congestive heart failure in the previous 6 months
• History of clinically significant ventricular arrhythmias of any type (as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
• History of second or third grade heart block (these patients may be eligible if you currently have a pacemaker)

Sponsors & Collaborators

• Grupo Español de Investigación en Neurooncología: lead
• Pfizer: collaborator

Study Sites (11)

Hospital Insular de Canarias

Las Palmas de Gran Canaria, Las Palmas, Spain

Location

Hospital Son Espases

Palma de Mallorca, Mallorca, Spain

Location

Consorcio Hospitalario Provincial de Castellón

Castellon, Valencia, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

ICO Hospitalet

Barcelona, Spain

Location

Hospital de León

León, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Regional de Málaga

Málaga, Spain

Location

Hospital Virgen del Rocio

Seville, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Oligodendroglioma; Astrocytoma

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: A responsibility person designate by sponsor
• Organization: MFAR

investigacion@mfar.net

934344412

Study Officials

• Juan Manuel Sepúlveda

  H. 12 de Octubre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 21, 2015
• Study Start: October 25, 2015
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-10

Locations

ES (11)