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NCT02552953
A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
Phase 1 trial testing CYC065 in Cancer in 60 participants. Completed in 25 August 2023.
4 October 2022
Quick facts
| Lead sponsor | Cyclacel Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 28 September 2015 |
| Primary completion | 4 October 2022 |
| Estimated completion | 25 August 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- CYC065 — full drug profile →
Conditions studied
- Cancer — all drugs for Cancer →
Sponsor
Cyclacel Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cyclin D1, cancer progression, and opportunities in cancer treatment.
Qie S, Diehl JA. · · 2016 · cited 527× · PMID 27695879 · DOI 10.1007/s00109-016-1475-3 -
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 -
The Renaissance of Cyclin Dependent Kinase Inhibitors.
Ettl T, Schulz D, Bauer RJ. · · 2022 · cited 50× · PMID 35053461 · DOI 10.3390/cancers14020293 -
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 -
Cyclins and cyclin-dependent kinases: from biology to tumorigenesis and therapeutic opportunities.
Zabihi M, Lotfi R, Yousefi AM, Bashash D. · · 2023 · cited 37× · PMID 35781526 · DOI 10.1007/s00432-022-04135-6 -
Role of Cyclin-Dependent Kinase Inhibitors in Endometrial Cancer.
Giannone G, Tuninetti V, Ghisoni E, Genta S, et al · · 2019 · cited 29× · PMID 31083638 · DOI 10.3390/ijms20092353 -
The Proliferative and Apoptotic Landscape of Basal-like Breast Cancer.
Alexandrou S, George SM, Ormandy CJ, Lim E, et al · · 2019 · cited 24× · PMID 30720718 · DOI 10.3390/ijms20030667 -
CDK9 inhibitors in multiple myeloma: a review of progress and perspectives.
Borowczak J, Szczerbowski K, Ahmadi N, Szylberg Ł. · · 2022 · cited 23× · PMID 35092513 · DOI 10.1007/s12032-021-01636-1
Verify or expand the search:
- PubMed search for NCT02552953
- 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.
- NCT04017546 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS · Phase 1 · completed
- NCT03739554 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL · Phase 1 · completed
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Currently open trials in the same condition.
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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
- NCT04017546 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS · Phase 1 · completed
- 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
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 NCT02552953 (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: 31 May 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/NCT02552953.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing