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NCT02552953

A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers

Completed Phase 1 Last updated 31 May 2024
What this trial tests

Phase 1 trial testing CYC065 in Cancer in 60 participants. Completed in 25 August 2023.

Timeline
28 September 2015
Primary endpoint
4 October 2022
25 August 2023

Quick facts

Lead sponsorCyclacel Pharmaceuticals, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment60
Start date28 September 2015
Primary completion4 October 2022
Estimated completion25 August 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. The Renaissance of Cyclin Dependent Kinase Inhibitors.
    Ettl T, Schulz D, Bauer RJ. · · 2022 · cited 50× · PMID 35053461 · DOI 10.3390/cancers14020293
  4. 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
  5. 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
  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
  7. 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
  8. 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

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