Last reviewed · How we verify
NCT04017546
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS
Completed
Phase 1
Last updated 19 September 2024
What this trial tests
Phase 1 trial testing CYC065 in AML in 14 participants. Completed in 5 April 2023.
Timeline
2 August 2019
Primary endpoint
15 November 2022
15 November 2022
5 April 2023
Quick facts
| Lead sponsor | Cyclacel Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 2 August 2019 |
| Primary completion | 15 November 2022 |
| Estimated completion | 5 April 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CYC065 — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
Conditions studied
Sponsor
Cyclacel Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with AML or MDS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Saga of Mcl-1: regulation from transcription to degradation.
Senichkin VV, Streletskaia AY, Gorbunova AS, Zhivotovsky B, et al · · 2020 · cited 128× · PMID 31907390 · DOI 10.1038/s41418-019-0486-3 -
New directions for emerging therapies in acute myeloid leukemia: the next chapter.
Daver N, Wei AH, Pollyea DA, Fathi AT, et al · · 2020 · cited 117× · PMID 33127875 · DOI 10.1038/s41408-020-00376-1 -
Venetoclax resistance: mechanistic insights and future strategies.
Ong F, Kim K, Konopleva MY. · · 2022 · cited 79× · PMID 35800373 · DOI 10.20517/cdr.2021.125 -
Fadraciclib (CYC065), a novel CDK inhibitor, targets key pro-survival and oncogenic pathways in cancer.
Frame S, Saladino C, MacKay C, Atrash B, et al · · 2020 · cited 68× · PMID 32645016 · DOI 10.1371/journal.pone.0234103 -
Mitophagy Promotes Resistance to BH3 Mimetics in Acute Myeloid Leukemia.
Glytsou C, Chen X, Zacharioudakis E, Al-Santli W, et al · · 2023 · cited 62× · PMID 37088914 · DOI 10.1158/2159-8290.cd-22-0601 -
Combination strategies to overcome resistance to the BCL2 inhibitor venetoclax in hematologic malignancies.
Yue X, Chen Q, He J. · · 2020 · cited 51× · PMID 33292251 · DOI 10.1186/s12935-020-01614-z -
The evolution of cyclin dependent kinase inhibitors in the treatment of cancer.
Jhaveri K, Burris Rd HA, Yap TA, Hamilton E, et al · · 2021 · cited 40× · PMID 34176404 · DOI 10.1080/14737140.2021.1944109 -
Emerging treatment options for patients with high-risk myelodysplastic syndrome.
Bewersdorf JP, Carraway H, Prebet T. · · 2020 · cited 24× · PMID 33240476 · DOI 10.1177/2040620720955006
Verify or expand the search:
- PubMed search for NCT04017546
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CYC065
Trials testing the same drug.
- NCT03739554 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL · Phase 1 · completed
- NCT02552953 — A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers · Phase 1 · completed
Other recruiting trials for AML
Currently open trials in the same condition.
- NCT06611839 — Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML · Phase 1, PHASE2 · recruiting
- NCT07163728 — Leptin: A Marker for AML Chemo-Sensitivity · recruiting
- NCT06973668 — A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophospham · Phase 2 · recruiting
- NCT07126782 — The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT · EARLY_PHASE1 · recruiting
- NCT06717958 — Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute M · Phase 2 · recruiting
Other Cyclacel Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT05817890 — Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects · EARLY_PHASE1 · completed
- NCT04983810 — A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma · Phase 1, PHASE2 · unknown
- NCT03884829 — A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS · Phase 1 · terminated
- NCT03739554 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL · Phase 1 · completed
- NCT02552953 — A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04017546 (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 Cyclacel Pharmaceuticals, Inc.
- Last refreshed: 19 September 2024
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/NCT04017546.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing