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NCT04074785: SCCC-06319
Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6
EARLY_PHASE1 trial testing Abemaciclib in GBM in 10 participants. Terminated before completion.
16 October 2023
Quick facts
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 13 December 2019 |
| Primary completion | 16 October 2023 |
| Estimated completion | 16 October 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Abemaciclib (abemaciclib) — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Conditions studied
- GBM — all drugs for GBM →
- Glioblastoma — all drugs for Glioblastoma →
- Brain Tumor — all drugs for Brain Tumor →
- Brain Tumor, Recurrent — all drugs for Brain Tumor, Recurrent →
Sponsor
University of Texas Southwestern Medical Center
Who can join
Adults 18 to 99, any sex, with GBM or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
CDK4 and CDK6 kinases: From basic science to cancer therapy.
Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495 -
Selective inhibition of CDK4/6: A safe and effective strategy for developing anticancer drugs.
Yuan K, Wang X, Dong H, Min W, et al · · 2021 · cited 103× · PMID 33532179 · DOI 10.1016/j.apsb.2020.05.001 -
Glioblastoma at the crossroads: current understanding and future therapeutic horizons.
Singh S, Dey D, Barik D, Mohapatra I, et al · · 2025 · cited 91× · PMID 40628732 · DOI 10.1038/s41392-025-02299-4 -
Therapeutic strategies of glioblastoma (GBM): The current advances in the molecular targets and bioactive small molecule compounds.
Liu H, Qiu W, Sun T, Wang L, et al · · 2022 · cited 58× · PMID 35847506 · DOI 10.1016/j.apsb.2021.12.019 -
Pathogenetic Features and Current Management of Glioblastoma.
Nguyen HM, Guz-Montgomery K, Lowe DB, Saha D. · · 2021 · cited 42× · PMID 33670551 · DOI 10.3390/cancers13040856 -
Cyclin-dependent kinase inhibitors in brain cancer: current state and future directions.
Juric V, Murphy B. · · 2020 · cited 39× · PMID 35582046 · DOI 10.20517/cdr.2019.105 -
Targeting CDK4/6 for Anticancer Therapy.
Qi J, Ouyang Z. · · 2022 · cited 32× · PMID 35327487 · DOI 10.3390/biomedicines10030685 -
Recurrent Glioblastoma: Ongoing Clinical Challenges and Future Prospects.
Pineda E, Domenech M, Hernández A, Comas S, et al · · 2023 · cited 27× · PMID 36721854 · DOI 10.2147/ott.s366371
Verify or expand the search:
- PubMed search for NCT04074785
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Abemaciclib
Trials testing the same drug.
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- NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
- NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
- NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
- NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation
Other recruiting trials for GBM
Currently open trials in the same condition.
- NCT05902169 — Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM · Phase 3 · active not recruiting
- NCT05879367 — Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma · Phase 1 · recruiting
- NCT05954858 — Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma · NA · recruiting
- NCT05933265 — Study of LP-184 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06018363 — Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection · Phase 1, PHASE2 · recruiting
Other University of Texas Southwestern Medical Center trials
Trials by the same sponsor.
- NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
- NCT06917183 — Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB) · NA · not yet recruiting
- NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
- NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
- NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04074785 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
- Last refreshed: 17 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04074785.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing