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OligodendrogliomaPhase 2NCT02530320

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

A Phase 2 study testing Palbociclib in people with Oligodendroglioma and Oligoastrocytoma, run by Grupo Español de Investigación en Neurooncología at 11 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oligodendroglioma, Oligoastrocytoma
What is being tested?
Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
11 sitesSpain
Study dates
25 Oct 2015to Mar 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • ECOG≤2
  • Stable or decreasing dose of corticoids during the five days prior to the inclusion
  • 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)
  • Hemoglobin ≥ 9 g/dL
  • Seric creatinine ≤ 1.5 x LSN of the site or estimated clearance ≥ 60 ml/min calculated.
  • Bilirubin ≤ 1.5 x LSN (if Gilbert's syndrome ≤ 3 xLSN) AST (SGOT) and/or ALT ≤ 3 x LSN; alkaline phosphatase ≤ 2.5 x LSN.
  • Nor pregnant women nor breast-feeding women. Women with heterosexual activity should have a negative pregnant test before the inclusion in the study. Both women and men should use an accepted contraceptive method during the study treatment and 1 month after treatment completed.

Who cannot join

  • 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.
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  • 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)
  • Ictus
  • Pulmonary embolism
  • History of any cancer, except for the following circumstances:
  • Patients with a history of other malignancies are eligible if they have been free of disease for at least the last 3 years, and at the discretion of the investigator, there is low risk of disease recurrence.
  • Patients with the following cancers are eligible even if they are diagnosed and treated in the last 3 years: carcinoma in situ of the cervix and basal cell or basal cell skin carcinoma. Patients are ineligible if there is evidence of any neoplastic disease that required therapy other than surgery in the past 3 years.
  • Patients positive for HIV
  • Inflammatory bowel disease, chronic diarrhea, short gut syndrome or any upper gastrointestinal surgery including gastric resection.
  • History of allergic reactions to Palbociclib
  • Another acute or chronic serious medical condition, uncontrolled intercurrent illness or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of test results and that,investigator's discretion, make the patient inappropriate for entry into this trial. Uncontrolled intercurrent illness including, but are not limited to, ongoing or active infection or psychiatric illness / social situations that limit the compliance of study requirements.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Spain11 sites

  • Hospital Clínic de Barcelona

    Barcelona

  • ICO Hospitalet

    Barcelona

  • Consorcio Hospitalario Provincial de Castellón

    Castellon, Valencia

  • Hospital Insular de Canarias

    Las Palmas de Gran Canaria, Las Palmas

  • Hospital de León

    León

  • Hospital 12 de Octubre

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Regional de Málaga

    Málaga

  • Hospital Son Espases

    Palma de Mallorca, Mallorca

  • Hospital Virgen del Rocio

    Seville

  • Hospital Universitario y Politécnico La Fe

    Valencia

Other trials in Spain

About this study

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

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.

Being tested
Palbociclib
Keywords
Palbociclib, oligodendroglioma, oligoastrocytoma anaplastic
Medical subject headings
Oligodendroglioma, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    Also called PD0332991

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

Study groups in NCT02530320
Study groupRoleWhat they receive
Palbociclib (PD0332991)ExperimentalPalbociclib 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.
Receives: Drug: Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) at Six Months (PFS6m)

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

    Measured: 6 months

Secondary outcomes (4)

  1. 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.)

    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.

    Measured: Three years

  2. Anti-tumor Response According to RANO Criteria

    According to RANO criteria, assessed by the PI of each center. There will be a central review.

    Measured: 30 months

  3. Overall Survival (OS)

    Time from randomization to death by any cause.

    Measured: With a median follow-up of 12 (0.9-52.2) months

  4. Changes in the Use of Glucocorticoids

    Percentage of patients decreasing doses of corticosteroids during treatment. Corticoids evolution

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2015 (estimated)
  2. Study start25 Oct 2015
  3. Primary completionDec 2019
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02530320
Sponsor's protocol ID
GEINO 13
Status last verified
Oct 2024
First submitted
18 Aug 2015
Last updated
22 Nov 2024
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib in people with Oligodendroglioma and Oligoastrocytoma, run by Grupo Español de Investigación en Neurooncología at 11 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) at Six Months (PFS6m) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02530320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.

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