Oligodendroglioma, AdultPhase 2NCT03969706
Abemaciclib in Patients With Oligodendroglioma
A Phase 2 study testing Abemaciclib 200 MG in people with Oligodendroglioma, Adult, run by Stephen Bagley, MD, MSCE at 1 site in United States.
Trial summary
This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oligodendroglioma, Adult
- What is being tested?
- Abemaciclib 200 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 2 Feb 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 12 weeks from the completion of radiation
- 6 weeks from a nitrosourea cytotoxic chemotherapy
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- 3 weeks from a non-nitrosourea cytotoxic chemotherapy
- 4 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
- Hemoglobin >= 8 g/dl. 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.
- Adequate hepatic function within 7 days prior to enrollment, defined as follows
- Total bilirubin ≤ 1.5 x ULN (patients with Gilbert's Syndrome with a total bilirubin ≤ 2.0 mg/dl and direct bilirubin within normal limits are permitted)
- ALT and AST ≤ 3x upper limit of normal (ULN)
- Adequate renal function within 7 days prior to enrollment, defined as follows:
- serum creatinine <=1.5 x institutional ULN OR calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) >=50 mL/min for subjects with creatinine levels >1.5x institutional ULN
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Single-Arm, Open-label, Phase II Study Evaluating the Efficacy and Safety of Abemaciclib in Patients With Recurrent Oligodendroglioma
This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma
Read the detailed description
Primary Objective:
- To determine the efficacy of abemaciclib for recurrent oligodendroglioma, as measured by the estimated proportion of patients alive without disease progression at 6 months from study enrollment (PFS-6)
Secondary Objectives:
- To evaluate the safety and tolerability of abemaciclib in recurrent oligodendroglioma
- To estimate the objective radiographic response rate (ORR) associated with abemaciclib in recurrent oligodendroglioma
- To determine the median progression-free survival (PFS) and overall survival (OS) of patients with recurrent oligodendroglioma treated with abemaciclib
- To determine ORR, PFS, and OS in the subgroup of recurrent oligodendroglioma patients with tumor CIC gene mutations
Exploratory Objectives:
- To measure pharmacodynamic markers of abemaciclib activity on oligodendroglial tumor cells
- To identify pre-treatment tumor characteristics that are associated with response to abemaciclib recurrent oligodendroglioma
- Conditions
- Oligodendroglioma, Adult
- Being tested
- Abemaciclib 200 MG
- Medical subject headings
- Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abemaciclib 200 MGDrug
Subjects will be treated with abemaciclib 200mg by mouth once every 12 hours. Dosing will be continuous and administered on a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Abemaciclib 200mg tablet PO twice daily administered on 28-day cycles Subjects remain on treatment until tumor progression or unacceptable toxicity. Receives: Drug: Abemaciclib 200 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after initiation of study therapy
Secondary outcomes (4)
Safety and Tolerability of This Therapy
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Measured: From initiation of study drug to 28 days after the end of treatment visit
Objective Radiographic Response (ORR)
measured by modified Response Assessment in Neuro-Oncology (RANO) criteria.
Measured: Up to 2 years
Progression Free Survival
defined as the time from date of enrollment until the earliest date of disease progression (as determined by modified RANO criteria) or death due to any cause
Measured: Up to 2 years
Overall Survival
defined as the time from date of enrollment until death from any cause
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start15 Oct 2019
- Primary completion15 Sep 2024
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oligodendroglioma, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- This is an open-label, single-institution, single-arm phase II study of the efficacy and safety of abemaciclib in patients with recurrent oligodendroglioma.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Bagley, MD, MSCE
- Sponsor type
- University, hospital or other
- Collaborators
- Abramson Cancer Center at Penn Medicine, University of Pennsylvania
- Responsible party
- Sponsor-investigator, Stephen Bagley, MD, MSCE, Abramson Cancer Center at Penn Medicine
- Investigators
- Stephen Bagley, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969706
- Sponsor's protocol ID
- UPCC 28318
- Status last verified
- Jun 2026
- First submitted
- 21 May 2019
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-label, Phase II Study Evaluating the Efficacy and Safety of Abemaciclib in Patients With Recurrent Oligodendroglioma
- ClinicalTrials.gov ID
- NCT03969706
- Acronym / sponsor ID
- UPCC 28318
- Conditions
- Oligodendroglioma, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stephen Bagley, MD, MSCEUniversity, hospital or other
- Collaborators
- Abramson Cancer Center at Penn Medicine, University of Pennsylvania
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Posted 25 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma
Detailed description
Primary Objective:
- To determine the efficacy of abemaciclib for recurrent oligodendroglioma, as measured by the estimated proportion of patients alive without disease progression at 6 months from study enrollment (PFS-6)
Secondary Objectives:
- To evaluate the safety and tolerability of abemaciclib in recurrent oligodendroglioma
- To estimate the objective radiographic response rate (ORR) associated with abemaciclib in recurrent oligodendroglioma
- To determine the median progression-free survival (PFS) and overall survival (OS) of patients with recurrent oligodendroglioma treated with abemaciclib
- To determine ORR, PFS, and OS in the subgroup of recurrent oligodendroglioma patients with tumor CIC gene mutations
Exploratory Objectives:
- To measure pharmacodynamic markers of abemaciclib activity on oligodendroglial tumor cells
- To identify pre-treatment tumor characteristics that are associated with response to abemaciclib recurrent oligodendroglioma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single-institution, single-arm phase II study of the efficacy and safety of abemaciclib in patients with recurrent oligodendroglioma.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Abemaciclib 200 MGAbemaciclib 200mg tablet PO twice daily administered on 28-day cycles Subjects remain on treatment until tumor progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Patients must be able to swallow oral medications
Key exclusion criteria (15 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abemaciclib 200 MGSubjects will be treated with abemaciclib 200mg by mouth once every 12 hours. Dosing will be continuous and administered on a 28-day cycle | Drug | Single Arm |
Primary outcome
Progression-free Survival
Time frame: 6 months after initiation of study therapy
Assessed as a) Tumor progression (as measured by modified RANO criteria) or death due to disease or toxicity; OR b) alive without tumor progression
4 secondary outcomes
Safety and Tolerability of This Therapy
Time frame: From initiation of study drug to 28 days after the end of treatment visit
Objective Radiographic Response (ORR)
Time frame: Up to 2 years
Progression Free Survival
Time frame: Up to 2 years
Overall Survival
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Bagley, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib 200 MG in people with Oligodendroglioma, Adult, run by Stephen Bagley, MD, MSCE at 1 site in United States.
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 21 inclusion and 15 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 25 Sep 2026). 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 (time frame: 6 months after initiation of study therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.