GBMEarly Phase 1SCCC-06319NCT04074785
Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6
A Early Phase 1 study testing Abemaciclib and Bevacizumab in people with GBM and Glioblastoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Describe the safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular aberrations Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- GBM, Glioblastoma, Brain Tumor
- What is being tested?
- Abemaciclib and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2019to 16 Oct 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed GBM at first or second recurrence after concurrent chemoradiotherapy. Patients with an initial diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined to be GBM. GBMs either from the initial resection or at repeat resection at recurrence must be analyzed by next-generation exome sequencing (NES) and RNA-sequencing and must have the following aberrations:
- Heterozygous or homozygous loss of CDKN2A and/or CDKN2B
- OR
- Gain or amplification of CDK4 and/or 6
- NOTE: Patients with GBMs having loss of function of RB1 are EXCLUDED.
- Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria. A minimum of 12 weeks must have elapsed from the completion of radiotherapy to study entry to minimize the potential for magnetic resonance imaging (MRI) changes related to radiation necrosis that might be misdiagnosed as progression of disease, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling.
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- Karnofsky performance status (KPS) ≥ 60%.
- Stable or decreasing dose of corticosteroids within 5 days prior to randomization.
- For women who are of child-bearing potential or surgically sterile (absence of ovaries and/or uterus) and who are sexually active: to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the treatment period and for at least 6 months after last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- For male patients who are partners of premenopausal women: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
- Surgery must have confirmed the recurrence.
- A minimum of 28 days must have elapsed from the day of surgery to study entry. For core or needle biopsy, a minimum of 7 days must have elapsed prior to study entry.
- Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization.
- Patients must be willing and able to provide written informed consent and to comply with the study protocol as judged by the investigator.
- Age ≥ 18 years.
- Patients must have recovered (Common Terminology Criteria for Adverse Events CTCAE] Grade ≤1) from the acute effects of chemotherapy prior to study entry. Minimum times from prior therapies include:
- ≥ 28 days elapsed from the administration of any investigational agent
- ≥ 28 days elapsed from the administration of any prior cytotoxic agents, except ≥ 42 days from nitrosoureas
- NOTE: Prior treatment with Novo-TTF therapy is allowed at initial diagnosis, but must be discontinued prior to study entry.
- Patients must be able to swallow oral medications.
- Ability to understand and the willingness to sign a written informed consent.
- Patients must have adequate organ and marrow function
Who cannot join
- Prior treatment with Bevacizumab, Abemaciclib, or any other CDK4/6 inhibitor or other systemic VEGF- or VEGF-receptor-targeted agent.
- Prior treatment with prolifeprospan 20 with carmustine wafer.
- Evidence of recent hemorrhage on baseline MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, or presence of punctuate hemorrhage in the tumor are eligible.
- Concurrent investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Patients unable to undergo brain MRI scans with IV gadolinium.
- Screening laboratory values outside of the values listed on Table 2.
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg while on antihypertensive medication).
- Uncontrolled diabetes despite maximal medical management.
- Prior history of hypertensive crisis or hypertensive encephalopathy.
- New York Heart Association Grade II or greater congestive cardiac failure.
- History of myocardial infarction (within 12 months) or unstable angina (within 6 months) prior to study entry.
- History of stroke or transient ischemic attacks within 6 months prior to study entry.
- Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study entry.
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to study entry.
- History of intracranial abscess within 6 months prior to randomization or active bacterial infection (requiring intravenous [IV] antibiotics within 2 weeks from initiation of study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive].
- Serious non-healing wound, active ulcer, or untreated bone fracture.
- History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are ELIGIBLE.
- Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibody.
- Taking any treatments listed in the Prohibited Concomitant Medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Abemaciclib With Bevacizumab in Recurrent Glioblastoma Patients With Loss of CDKN2A/B or Gain or Amplification of CDK4/6
Describe the safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular aberrations
- Conditions
- GBM, Glioblastoma, Brain Tumor, Brain Tumor, Recurrent
- Being tested
- Abemaciclib, Bevacizumab
- Keywords
- Abemaciclib, Bevacizumab, CDKN2A/B, CDK4/6, Verzenio, Avastin
- 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 Verzenio
Abemaciclib 150 mg po bid
BevacizumabDrug
Also called Avastin
Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Safety Run-In | Experimental | Abemaciclib 150 mg po bid PLUS Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles Receives: Drug: Abemaciclib; Drug: Bevacizumab |
| Abemaciclib with Bevacizumab | Experimental | Abemaciclib 100 mg po bid PLUS Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles Receives: Drug: Abemaciclib; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse event
Assess safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular aberrations.
NCI Common terminology criteria for adverse events (CTCAE v.5) will be used to assess the adverse events.
Measured: upto 2 years after study treatment
Secondary outcomes (2)
Median Overall Survival
Median OS of the study patients from time of study entry until death or lost to follow-up.
Measured: upto 2 years after study treatment
Median Progression Free Survival
Median PFS of the study patients from time of study entry until progression as determined by the Response Assessment in Neuro-Oncology (RANO) criteria [30].
Measured: upto 2 years after study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start13 Dec 2019
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Why it stopped: Administratively closed by the IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBMStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Bachoo, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074785
- Sponsor's protocol ID
- STU-2019-1214
- Acronym
- SCCC-06319
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2019
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Abemaciclib With Bevacizumab in Recurrent Glioblastoma Patients With Loss of CDKN2A/B or Gain or Amplification of CDK4/6
- ClinicalTrials.gov ID
- NCT04074785
- Acronym / sponsor ID
- SCCC-06319 / STU-2019-1214
- Conditions
- GBM, Glioblastoma, Brain Tumor, Brain Tumor, Recurrent
- Keywords
- Abemaciclib, Bevacizumab, CDKN2A/B, CDK4/6, Verzenio, Avastin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively closed by the IRB.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Describe the safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular aberrations
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Run-In | Experimental | Drug: Abemaciclib, Drug: BevacizumabAbemaciclib 150 mg po bid PLUS Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles |
| Abemaciclib with Bevacizumab | Experimental | Drug: Abemaciclib, Drug: BevacizumabAbemaciclib 100 mg po bid PLUS Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Histologically confirmed GBM at first or second recurrence after concurrent chemoradiotherapy. Patients with an initial diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined to be GBM. GBMs either from the initial resection or at repeat resection at recurrence must be analyzed by next-generation exome sequencing (NES) and RNA-sequencing and must have the following aberrations:
- Heterozygous or homozygous loss of CDKN2A and/or CDKN2B
- OR
- Gain or amplification of CDK4 and/or 6
- NOTE: Patients with GBMs having loss of function of RB1 are EXCLUDED.
Key exclusion criteria (23 listed)
- Prior treatment with Bevacizumab, Abemaciclib, or any other CDK4/6 inhibitor or other systemic VEGF- or VEGF-receptor-targeted agent.
- Prior treatment with prolifeprospan 20 with carmustine wafer.
- Evidence of recent hemorrhage on baseline MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, or presence of punctuate hemorrhage in the tumor are eligible.
- Concurrent investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.
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 |
|---|---|---|
| AbemaciclibAlso: VerzenioAbemaciclib 150 mg po bid | Drug | Abemaciclib with Bevacizumab, Safety Run-In |
| BevacizumabAlso: AvastinBevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles | Drug | Abemaciclib with Bevacizumab, Safety Run-In |
Primary outcome
Number of participants with adverse event
Time frame: upto 2 years after study treatment
Assess safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular aberrations. NCI Common terminology criteria for adverse events (CTCAE v.5) will be used to assess the adverse events.
2 secondary outcomes
Median Overall Survival
Time frame: upto 2 years after study treatment
Median Progression Free Survival
Time frame: upto 2 years after study treatment
Results and safety
The study was stopped early (reason given: Administratively closed by the IRB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Abemaciclib and Bevacizumab in people with GBM and Glioblastoma, run by University of Texas Southwestern Medical Center 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 26 inclusion and 23 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: stopped early, as of the sponsor's last update on 17 Aug 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively closed by the IRB.). Results are not available in the source record.
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?
Number of participants with adverse event (time frame: upto 2 years after study treatment). 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 17 Aug 2025.