Abemaciclib in Patients with Oligodendroglioma

NCT03969706 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: UPCC 28318
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma

Conditions

Oligodendroglioma, Adult

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Assessed as a) Tumor progression (as measured by modified RANO criteria) or death due to disease or toxicity; OR b) alive without tumor progression

  6 months after initiation of study therapy

Secondary Outcomes (4)

• Safety and tolerability of this therapy

  From initiation of study drug to 28 days after the end of treatment visit

• Objective radiographic response (ORR)

  Up to 2 years

• Progression Free Survival

  Up to 2 years

• Overall Survival

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Abemaciclib 200mg tablet PO twice daily administered on 28-day cycles Subjects remain on treatment until tumor progression or unacceptable toxicity.

Drug: Abemaciclib 200 MG

Interventions

Abemaciclib 200 MG DRUG

Subjects will be treated with abemaciclib 200mg by mouth once every 12 hours. Dosing will be continuous and administered on a 28-day cycle

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and molecularly confirmed diagnosis of oligodendroglioma according to 2016 WHO Classification (tumor tissue must show co-deletion of chromosomes 1p and 19q, referred to as "1p/19q codeletion").
• Oligodendroglioma must be progressive or recurrent following BOTH a) prior radiation therapy and b) at least one prior line of alkylating chemotherapy.
• Patients may have had treatment for an unlimited number of prior relapses.. Recent surgical resection for recurrence is allowed, as long as there remains measurable contrast-enhancing disease after surgery.
• Patients must have recovered from severe toxicity of prior therapy. Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE v. 5.0\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to enrollment. The following intervals from previous treatments are required to be eligible:
• weeks from the completion of radiation
• weeks from a nitrosourea cytotoxic chemotherapy
• weeks from a non-nitrosourea cytotoxic chemotherapy
• weeks from any investigational (not Food and Drug Administration \[FDA\]-approved for oligodendroglioma or other gliomas) agents
• Patients must be able to swallow oral medications
• Age 18 or older
• Karnofsky performance status \>= 60
• Life expectancy \>3 months
• Adequate hematologic parameters, including:
• Absolute neutrophil count \>= 1,500/ul
• Platelets \>= 100,000/ul

You may not qualify if:

• Any of the following would exclude the subject from participation in the study:
• Prior treatment with a CDK4/6 inhibitor
• Patients must not be on enzyme-inducing anti-epileptic drugs (EIAEDs; carbamazepine, phenytoin, and phenobarbitol)
• The patient has serious preexisting medical condition(s) 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)
• Females who are pregnant or lactating are excluded.
• 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.
• Women must agree not to breast feed while on abemaciclib treatment and for at least three months following the last dose of study therapy.
• The patient has active bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C). Patients with known HIV infection are excluded given the potential for interactions between antiretroviral agents and abemaciclib. Patients with known Hepatitis B or Hepatitis C infection are excluded only if there is evidence of active infection (detectable Hepatitis B surface antigen, detectable Hepatitis C RNA). For patients without known viral hepatitis or HIV infection, viral hepatitis and HIV testing are NOT required to determine eligibility for this trial.
• The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
• Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.
• Prisoners or subjects who are involuntarily incarcerated are excluded.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness are excluded
• Subjects requiring concurrent administration of any other anticancer agents including chemotherapy and biologic agents (such as bevacizumab) or the use of other concurrent investigational treatment drugs and/or devices.

Sponsors & Collaborators

• Stephen Bagley, MD, MSCE: lead
• Abramson Cancer Center at Penn Medicine: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Oligodendroglioma

Interventions

abemaciclib

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

Study Officials

• Stephen Bagley, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This is an open-label, single-institution, single-arm phase II study of the efficacy and safety of abemaciclib in patients with recurrent oligodendroglioma.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 31, 2019
• Study Start: May 15, 2019
• Primary Completion: May 15, 2025
• Study Completion (Estimated): May 15, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)