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

Last updated date
Study Location
Hospital Insular de Canarias
Las Palmas de Gran Canaria, Las Palmas, , Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Oligodendroglioma, Oligoastrocytoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Ability to understand and sign the informed consent approved by the Ethic Committee.

2. Men or women aged greater than or equal to 18.

3. 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.

4. 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.

5. All patients have to present positivity in immunohistochemical study for the RB protein in the tumor samples sent to the central lab.

6. The cases must have 10 slides or a tumor block available from a biopsy or surgery.

7. All patients have to show disease progression in a cerebral nuclear magnetic resonance.

8. Interval of at least one week between the previous intracranial biopsy and the inclusion.

9. 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.

10. 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.

11. ECOG≤2

12. Stable or decreasing dose of corticoids during the five days prior to the inclusion

13. 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

14. 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.

15. 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Presence of meningeal carcinomatosis disseminated.


2. Concomitant treatment with other investigational products


3. Previous treatment wih an investigational product that could be active for CDK4/6


4. Any kind of surgery in the previous 2 weeks


5. 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.


6. 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.


7. 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


8. QTc interval >480 msec, familiar history or personal of QT large Syndrome, QT short
Syndrome, Brugada syndrome, QTc extension or Torsade de Pointes history


9. Electrolyte disorder that may affect the QTc interval


10. 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


11. 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.


12. Patients positive for HIV


13. Inflammatory bowel disease, chronic diarrhea, short gut syndrome or any upper
gastrointestinal surgery including gastric resection.


14. History of allergic reactions to Palbociclib


15. 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.

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Oligodendroglioma, OligoastrocytomaSafety 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
  1. Las Palmas de Gran Canaria, Las Palmas
  2. Palma de Mallorca, Mallorca
  3. Barcelona,
  4. Barcelona,
  5. León,
  6. Madrid,
  7. Madrid,
  8. Málaga,
  9. Sevilla,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Oligodendroglioma
  • Oligoastrocytoma
Intervention  ICMJE Drug: Palbociclib
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
Study Arms  ICMJE 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.
Intervention: Drug: Palbociclib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2020
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ability to understand and sign the informed consent approved by the Ethic Committee.
  2. Men or women aged greater than or equal to 18.
  3. 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.
  4. 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.
  5. All patients have to present positivity in immunohistochemical study for the RB protein in the tumor samples sent to the central lab.
  6. The cases must have 10 slides or a tumor block available from a biopsy or surgery.
  7. All patients have to show disease progression in a cerebral nuclear magnetic resonance.
  8. Interval of at least one week between the previous intracranial biopsy and the inclusion.
  9. 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.
  10. 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.
  11. ECOG?2
  12. Stable or decreasing dose of corticoids during the five days prior to the inclusion
  13. 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
  14. 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.
  15. 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.

Exclusion Criteria:

  1. Presence of meningeal carcinomatosis disseminated.
  2. Concomitant treatment with other investigational products
  3. Previous treatment wih an investigational product that could be active for CDK4/6
  4. Any kind of surgery in the previous 2 weeks
  5. 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.
  6. 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.
  7. 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
  8. QTc interval >480 msec, familiar history or personal of QT large Syndrome, QT short Syndrome, Brugada syndrome, QTc extension or Torsade de Pointes history
  9. Electrolyte disorder that may affect the QTc interval
  10. 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
  11. 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.
  12. Patients positive for HIV
  13. Inflammatory bowel disease, chronic diarrhea, short gut syndrome or any upper gastrointestinal surgery including gastric resection.
  14. History of allergic reactions to Palbociclib
  15. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02530320
Other Study ID Numbers  ICMJE GEINO 13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grupo Español de Investigación en Neurooncología
Study Sponsor  ICMJE Grupo Español de Investigación en Neurooncología
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Juan Manuel SepúlvedaH. 12 de Octubre
PRS Account Grupo Español de Investigación en Neurooncología
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP