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GlioblastomaPhase 2NCT02981940

A Study of Abemaciclib in Recurrent Glioblastoma

A Phase 2 study testing Abemaciclib and Surgery in people with Glioblastoma, run by Dana-Farber Cancer Institute at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research study is studying a targeted therapy as a possible treatment for recurrent glioblastoma (GBM). The following intervention will be used in this study: -Abemaciclib Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Abemaciclib and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
7 sitesUnited States
Study dates
9 Feb 2017to 30 Jun 2027
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

  • Participants must be able to understand and willing to sign a written informed consent document.
  • Participants must be able to adhere to the dosing and visit schedules, and agree to record medication times accurately and consistently in a daily diary.
  • Participants must be at least 18 years old on day of signing informed consent.
  • Participants must have a Karnofsky Performance Status (KPS) ≥ 60
  • Participants must be able to swallow capsules/tablets
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy of the trial are eligible.
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  • Nature of illness and treatment history
  • Participants must undergo central pathology review to histologically confirm the diagnosis of glioblastoma, IDH-wildtype; glioblastoma variants; or astrocytoma, IDH-mutant, WHO grade 4 (1 unstained slide or 1 H\&E slide must be submitted to and reviewed by a pathologist at the DFCI Coordinating Center prior to enrollment of the participant for central pathology review).
  • To be eligible for the study all participants (Cohort 1 and 2) are required to provide genomic profiling data from assays performed in a CLIA-certified lab. A sequencing-based assay is required and must include reporting of the RB1 gene in explicit terms within the report. Only sequencing assays that include coverage of all exons of the RB1 gene are able to be utilized (most commonly called a targeted exome assay; e.g. Oncopanel, Impact, FoundationOne). In addition, patients must provide a report of copy assessment which reports status of RB1. The reporting may be from a copy array (ideally Oncoscan SNP array or Agilent array CGH) or can also be from sequencing assay if copy status is explicitly provided with quantitative information regarding the status of relevant genes. Specifically, the reporting should provide the following information with respect to relevant biomarkers required for enrollment to the study as listed below.
  • Results from genomic profiling must be sent to the DFCI Coordinating Center prior to enrollment of the participant for central pathology review.
  • Inactivation of CDKN2A/B or C in the tumor by homozygous deletion (evidence for more than single copy loss for any of the genes defined as array CGH/SNP log2 ratio of <0.3 by array CGH; or from sequencing data with sufficient coverage for evaluation). Rearrangement/evidence or intragenic breaks by copy or sequencing assay also will be considered eligible for study (any copy status).
  • OR
  • CDK4 or CDK6 high-level amplification. (The amplicon size must be <10Mb and the magnitude the gain must be log2 ratio >1.5 or estimated as >10 copies).
  • AND
  • Validation of wild-type RB status (no deletion/losses more than single copy by copy number or sequencing data; and/or no inactivating mutations by sequencing).
  • Participants must be at first relapse of GBM. Relapse is defined as progression following initial therapy (i.e. radiation+/- chemo if that was used as initial therapy). The intent therefore is that patients had no more than 1 prior therapy (initial treatment). If the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered to constitute 1 relapse.
  • Participants must have shown unequivocal evidence for tumor progression by MRI or CT scan.
  • For Cohort 2 subjects, CT or MRI within 14 days prior to study registration. For Cohort 2, corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required.
  • For Cohort 1 subjects, CT or MRI should be performed ideally within 14 days prior to study registration, but because the screening MRI for this subset of subjects will not be used for evaluation of response, it is acceptable for this MRI/CT to have been performed greater than 14 days prior to registration if unavoidable. Furthermore, for this same reason, fluctuation in corticosteroid dose around this MRI does not warrant repeat scan so long as there is documented unequivocal evidence of tumor progression available.
  • For Cohort 1 subjects, there must be > 2cm2 enhancing tissue available for resection and submission for study correlatives as determined by local treating team.
  • Confirmation of availability of sufficient tissue from a prior surgery for correlative studies is required prior to enrollment; these samples must be sent to the DFCI Coordinating Center within 60 days of registration. Cohort 1 participants must have sufficient FFPE tissue from any surgery. Cohort 2 participants must have tissue from biopsy or resection from the most recent recurrence surgery.
  • The following amount of archived tissue is required:
  • 20 unstained formalin fixed paraffin embedded (FFPE) sections (standard 4-5 micrometer thickness)
  • NOTE: if the above-mentioned tissue is not available from the most recent surgery revealing GBM, participants may be enrolled with tissue available from any prior surgery revealing GBM with prospective approval from the Overall PI.
  • An interval of at least 12 weeks from the completion of radiation therapy to start of study drug unless there is a new area of enhancement consistent with recurrent tumor outside the radiation field (defined as the region outside the high-dose region or 80% isodose line) or there is unequivocal histologic confirmation of tumor progression.
  • Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (including but not limited to exceptions of alopecia, laboratory values listed per inclusion criteria, and lymphopenia which is common after therapy with temozolomide).
  • From the projected start of scheduled study treatment, the following time periods must have elapsed:
  • 4 weeks or 5 half-lives (whichever is shorter) from any investigational agent;
  • 4 weeks from cytotoxic therapy (except 23 days for temozolomide; 6 weeks from nitrosoureas);
  • 4 weeks from antibodies;
  • 4 weeks or 5 half-lives (whichever is shorter) from other anti-tumor therapies.
  • 2 days from Novo-TTF
  • Participants with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of progressive disease based upon nuclear imaging, MR spectroscopy, perfusion imaging or histopathology.
  • Participants having undergone recent resection or open biopsy or stereotactic biopsy of recurrent or progressive tumor will be eligible for Cohort 2 as long as the following conditions apply:
  • They have recovered from the effects of surgery.
  • Residual disease following resection of recurrent tumor is not mandated for eligibility. To best assess the extent of residual disease post-operatively, an MRI or CT scan should ideally have been performed no later than 96 hours following surgery, or at least 28 days post-operatively, but scans performed outside of this window are considered acceptable if no alternative is available. In either case, the baseline/screening MRI must be performed within 14 days prior to registration. If the participant is taking corticosteroids, the dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening MRI or CT scan and the start of treatment, a new baseline MRI or CT is required.
  • Clinical labs - performed within 14 days prior to registration
  • Hematology:
  • Absolute neutrophil count (ANC) ≥ 1.5 x K/µL
  • Platelet count ≥ 100 x K/µL
  • Hemoglobin ≥ 8.0 g/dL
  • Biochemistry:
  • Total serum calcium (corrected for serum albumin as needed) or ionized calcium within institution's normal range.
  • Magnesium within institution's normal range.
  • AST (SGOT) and ALT (SGPT) ≤ 3.0 x institution's ULN
  • Serum bilirubin ≤ 1.5 x institution's ULN
  • Serum creatinine ≤ 1.5 x institution's ULN or calculated 24-hour creatinine clearance ≥ 50 mL/min
  • Serum amylase ≤ 1.5 x institution's ULN
  • Serum lipase ≤ 1.5 x institution's ULN
  • Coagulation studies:
  • INR < 2.0
  • PTT ≤ institution's ULN, unless receiving therapeutic low molecular weight heparin or oral factor Xa inhibitors Pregnancy and Reproduction
  • The effects of abemaciclib on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) must agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of abemaciclib. Men must agree to use a reliable method of birth control and to not donate sperm during the study 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: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
  • Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first dose of abemaciclib .

Who cannot join

  • Pathology
  • Prior evidence of 1p/19q co-deletion.
  • IDH1/2 mutation in any prior biopsy.
  • Previous therapies
  • Participants who have received prior treatment with a CDK4/6 inhibitor.
  • Participants who have received anti-VEGF targeted agents (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL184, sunitinib etc).
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  • Concomitant medications
  • Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participants must be off any EIAEDs for at least 14 days prior to starting study drug. A list of EIAEDs and other inducers of CYP3A4 can be found.
  • Participants taking a drug known to be a strong inhibitor or inducer of isoenzyme CYP3A . Participant must be off CYP3A inhibitors and inducers for at least 14 days prior to starting study drug. NOTE: participants must avoid consumption of Seville oranges (and juice), grapefruits or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to the first dose of study drug and during the entire study treatment period due to potential CYP3A4 interaction.
  • Participants receiving any other investigational agents.
  • Current use of herbal preparations/medications, including but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, ginseng. Participants should stop using these herbal medications 7 days prior to first dose of study drug.
  • Current use of warfarin sodium or any other coumadin-derivative anticoagulant. Participants must be off Coumadin-derivative anticoagulants for at least 7 days prior to starting study drug. Low molecular weight heparin is allowed.
  • Requires treatment with high dose systemic corticosteroids defined as dexamethasone > 4 mg/day or bioequivalent for at least 3 consecutive days within 2 weeks of registration.
  • Other illnesses
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to abemaciclib.
  • History of intratumoral or peritumoral hemorrhage if deemed significant by the treating investigator. If there are questions, the treating investigator should contact the study Overall P.I., Eudocia Quant Lee, MD, at 617-632-2166 or eqlee@partners.org.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations.
  • Participant has an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen or hepatitis C antibodies).
  • Participants with diarrhea ≥ CTCAE grade 2
  • Participant has active cardiac disease including any of the following:
  • Angina pectoris that requires the use of anti-anginal medications
  • Ventricular arrhythmias except for benign premature ventricular contractions
  • Supraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication
  • Conduction abnormality requiring a pacemaker
  • Valvular disease with document compromise in cardiac function
  • Symptomatic pericarditis
  • Participant has a history of cardiac dysfunction including any of the following:
  • Myocardial infarction within the last 6 months prior to start of study drug, documents by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV, see Appendix B)
  • Documented cardiomyopathy
  • Congenital long QT syndrome
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of abemaciclib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection). Participants with unresolved diarrhea ≥ CTCAE grade 2 will be excluded as previously indicated.
  • Participants who have undergone major systemic surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
  • Participants who are pregnant or breastfeeding.
  • Participants with history of known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 12 months of start of study drug.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • UT, M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California, San Francisco

    San Francisco, California, 94143-0372

Other trials in United States

About this study

Official title: A Phase 0/2 Study of Abemaciclib in Recurrent Glioblastoma

This research study is studying a targeted therapy as a possible treatment for recurrent glioblastoma (GBM).

The following intervention will be used in this study:

-Abemaciclib

Read the detailed description

This research study is a Phase 0/II clinical trial. Phase 0 clinical trials use only a few small doses of a drug. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved abemaciclib as a treatment for any disease.

Many brain cancers show over expression of a protein called cyclin D1. That means that the body makes too much cyclin D1, which affects enzymes called CDK 4 and CDK 6. Enzymes are substances in the body that help reactions between cells happen. Too much cyclin D1 triggers CDK 4 and CDK 6 to make more cells than normal. This extra cell production leads to the growth of tumors.

In laboratory studies, Abemaciclib was able to enter the brain, stop CDK 4 and CDK 6 from making cells, and slow growth of mice Glioblastoma.

In this research study, the investigators are looking to see how safe and effect Abemaciclib is with the participant type of cancer. In the surgical participants, the investigators are looking to see if Abemaciclib reached the brain tumor.

Conditions
Glioblastoma
Being tested
Abemaciclib, Surgery
Keywords
Brain Tumor
Medical subject headings
Glioblastoma, Brain Neoplasms

What participants receive

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

  • AbemaciclibDrug

    Also called LY2835219

    Abemaciclib capsule

  • SurgeryProcedure or surgery

    Surgery

Study groups in NCT02981940
Study groupRoleWhat they receive
Abemaciclib with SurgeryExperimental* Abemaciclib will be administered on a continuous twice daily dosing schedule * Patients who require re-operation will receive a short preoperative course of Abemaciclib * Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier. * After recovery from surgery, participants will resume Abemaciclib. Each cycle lasts 28 days. * NOTE: enrollment to this arm is complete
Receives: Drug: Abemaciclib; Procedure: Surgery
Abemaciclib without SurgeryExperimental* Abemaciclib will be administered on a continuous twice daily dosing schedule. Each Cycle last 28 days. * NOTE: enrollment to this arm is complete
Receives: Drug: Abemaciclib
Cohort 1 Surgery ArmExperimentalParticipants who require reoperation will be treated with abemaciclib for 10-14 days prior to surgery. Tissue will be used to further investigate the abilities of Abemaciclib. After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
Receives: Drug: Abemaciclib; Procedure: Surgery

What is being measured

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

  1. Intratumoral Abemaciclib Concentration

    Intratumoral abemaciclib concentration defined as the mean tumor-to-plasma ratio in contrast enhancing tissue. Patients were treated with abemaciclib prior to surgery. Tissue and plasma for analysis of this endpoint were obtained at the time of surgery.

    Measured: Single time point for each participant for collection of tissue and blood at surgery

  2. 6-Month Progression Free Survival (PFS6)

    The primary endpoint for the nonsurgical cohort was six-month progression free survival (PFS6). Progression is defined by Response Assessment in Neuro-Oncology criteria for high-grade glioma (RANO-HGG) as > 25% increase in sum of the products of perpendicular diameters of enhancing lesions (over best response or baseline if no decrease) on stable or increasing doses of corticosteroids AND/OR one or more of the following: significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids steroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events (radiation therapy, demyelination, ischemic injury, infection, seizures, post-operative changes, or other treatment effects); any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; or failure to return for evaluation due to death or deteriorating condition.

    Measured: 6 months

Secondary outcomes (7)

  1. pRB Expression Level of Tumor Tissue

    Expression of levels of phosphorylated retinoblastoma (Rb) to determine if abemaciclib is modulating the intended pathway

    Measured: 2 years

  2. Incidence of Treatment-Emergent Adverse Events

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 2 years

  3. Area Under the Plasma Concentration Versus Time Curve (AUC)

    PK measurements expressed as Area under the plasma concentration versus time curve (AUC) of Abemaciclib [Time Frame C1D1 (pre-treatment), C2D1, C3D1 and C4D1 (each cycle is 28 days)].

    Measured: 4 months

  4. Peak Plasma Concentration (Cmax)

    PK measurements expressed as Peak Plasma Concentration (Cmax) of Abemaciclib [Time Frame C1D1 (pre-treatment), C2D1, C3D1 and C4D1 (each cycle is 28 days)]

    Measured: 4 months

  5. Radiographic Response Rate

    The proportion of participants with measurable disease who experience complete or partial radiographic response determined by the RANO Criteria

    Measured: 2 years

  6. Median Progression Free Survival

    The time from the start of treatment to disease progression or death from any cause

    Measured: 2 years

  7. Overall Survival

    Time from start of study treatment to death from any cause

    Measured: 2 years

Timeline

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

  1. First posted5 Dec 2016 (estimated)
  2. Study start9 Feb 2017
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2027 (estimated)

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
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02981940
Sponsor's protocol ID
16-383
Status last verified
Aug 2026
First submitted
7 Oct 2016
Last updated
4 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib and Surgery in people with Glioblastoma, run by Dana-Farber Cancer Institute at 7 sites 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 55 inclusion and 35 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: under way, not looking for participants, as of the sponsor's last update on 4 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 7 sites 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 2 Sep 2025). 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?

Intratumoral Abemaciclib Concentration (time frame: Single time point for each participant for collection of tissue and blood at surgery). The study lists 2 primary outcomes in all. 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 NCT02981940.

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 4 Sep 2026.

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