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The Purpose of This Study is to Test Any Good and Bad Effects of a Study Drug Called Abemaciclib (LY2835219) in Patients With Recurrent Brain Tumors.

NCT03220646

Description:

The purpose of this study is to test any good and bad effects of a study drug called abemaciclib (LY2835219) in patients with recurrent brain tumors.

Related Conditions:
  • Astrocytoma
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Meningioma
  • Oligodendroglioma
  • Primary Central Nervous System Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: The Purpose of This Study is to Test Any Good and Bad Effects of a Study Drug Called Abemaciclib (LY2835219) in Patients With Recurrent Brain Tumors.
  • Official Title: A Phase 2 Study of Abemaciclib in Patients With Recurrent Brain Tumors

Clinical Trial IDs

  • ORG STUDY ID: 17-261
  • NCT ID: NCT03220646

Conditions

  • Brain Tumor

Interventions

DrugSynonymsArms
abemaciclibA:recurrent IDH wildtype RB1 intact grade II and III gliomas
abemaciclibB:Recurrent glioma any grade

Purpose

The purpose of this study is to test any good and bad effects of a study drug called abemaciclib (LY2835219) in patients with recurrent brain tumors.

Trial Arms

NameTypeDescriptionInterventions
A:recurrent IDH wildtype RB1 intact grade II and III gliomasExperimentalThe main study cohort will consist of patients with recurrent IDH wildtype, RB1 wildtype, WHO grade II and III gliomas that have failed previous therapy.
  • abemaciclib
B:Recurrent glioma any gradeExperimentalTen patients who require standard of care cytoreductive surgery for recurrent astrocytoma, oligodendroglioma, or glioblastoma, will be offered pre-surgical abemaciclib and then resume the drug following recovery from surgery, continuing until disease progression or unacceptable toxicity analogous to the non-surgical patients in cohort A and C.
  • abemaciclib
C:All other recurrent brain tumorsExperimentalThis is an exploratory cohort including patients with recurrent IDH mutant glioma, meningioma, recurrent CDKN2A/B deficient glioblastoma, recurrent ependymoma, and recurrent PCNSL.
  • abemaciclib

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must provide written informed consent prior to any screening procedures.

          -  Age 18 years or older.

          -  KPS ≥ 60

          -  Willing and able to comply with scheduled visits, treatment plan and laboratory tests

          -  Patient is able to swallow and retain oral medication

          -  Required baseline laboratory status:

               -  Hemoglobin > 8 g/dL (SI Units: 80 g/L). Patients may receive erythrocyte
                  transfusions to achieve this hemoglobin level at the discretion of the
                  investigator. Initial treatment must not begin earlier than the day after the
                  erythrocyte transfusion.

               -  Platelet count ≥ 100 x 10^9/L

               -  Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without growth factor support

               -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

               -  AST/SGOT and/or ALT/SGPT ≤ 3 x ULN

               -  Serum Creatinine ≤ 1.5 x ULN

          -  Stable dose of corticosteroids for > 5 days prior to baseline MRI

          -  Before starting study treatment, patients must have recovered from toxic effects of
             prior therapies (except for residual alopecia or Grade 2 peripheral neuropathy) and at
             least 3 weeks must have elapsed since any prior signaling pathway modulators, (e.g.,
             EGFR, FGFR, or other tyrosine kinase inhibitors), at least 3 weeks must have elapsed
             since temozolomide, 4 weeks must have elapsed since carboplatin or cisplatin, and at
             least 6 weeks from nitrosoureas (e.g., BCNU, CCNU). In general, at least 4 weeks must
             have elapsed from any other anticancer therapy (e.g. bevacizumab).

          -  Patients must be able to undergo contrast enhanced MRI scans (or contrast enhanced CT
             scans for patients unable to tolerate MRI).

          -  Patients must have shown unequivocal evidence for contrast enhancing tumor progression
             by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan. The
             same type of scan, i.e., MRI (or CT for patients who cannot undergo MRI) must be used
             throughout the period of protocol treatment for tumor measurement.

          -  Life expectancy of greater than 8 weeks

          -  If a female of childbearing potential, must have a negative serum pregnancy test
             within 7 days of the first dose of abemaciclib and agree to use a medically approved
             contraceptive method during the treatment period and for 3 months following the last
             dose of abemaciclib. If a male, agree to use a reliable method of birth control and to
             not donate sperm during the treatment period and for at least 3 months following the
             last dose of abemaciclib. Contraceptive methods may include an intrauterine device
             [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent
             should be added as a double barrier protection.

        Note: Cases of pregnancy that occur during maternal exposures to abemaciclib should be
        reported. If a patient or spouse/partner is determined to be pregnant following abemaciclib
        initiation, she must discontinue treatment immediately. Data on fetal outcome and
        breast-feeding are collected for regulatory reporting and drug safety evaluation.

          -  Women must agree not to breast feed while on abemaciclib treatment and for at least
             three months following the last dose of study therapy.

        Exclusion Criteria:

          -  No limit on number of prior therapies

          -  Evidence of significant intracranial hemorrhage

          -  No other investigational or standard anti-tumor therapy allowed

          -  Patients must not have a known history of allergic reactions attributed to compounds
             of similar chemical or biologic composition.

          -  Patients must not have a serious preexisting medical condition(s) or uncontrolled
             intercurrent illness that would preclude participation in this study (for example,
             interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history
             of major surgical resection involving the stomach or small bowel, or preexisting
             Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in
             baseline Grade 2 or higher diarrhea) or psychiatric illness/social situations that
             would limit compliance with study requirements.

          -  Patients who have a personal history of any of the following conditions: syncope of
             cardiovascular etiology, ventricular arrhythmia of pathological original (including,
             but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden
             cardiac arrest.

          -  HIV-positive patients on combination antiretroviral therapy are ineligible because of
             the potential for pharmacokinetic interactions. This applies only to patients who have
             a documented history of HIV; HIV testing is not otherwise required.

          -  Have an active systemic fungal and/or known viral infection (for example, human
             immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C
             antibodies)

          -  Patients must not be on EIAEDs

          -  Females who are pregnant or lactating

          -  Must abstain from grapefruit juice

          -  Patients must not have other active concurrent malignancy

          -  Concurrent treatment on another clinical trial. Supportive care trials or
             non-therapeutic trials (i.e. Quality of life) are allowed.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:radiographic response rate
Time Frame:6 months
Safety Issue:
Description:MRI (or CT) scan by RANO criteria.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Abemaciclib (LY2835219)
  • 17-261

Last Updated

August 7, 2017