Clinical trial · Interventional
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS
A Phase I Combination Study of CYC065 and Venetoclax in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
NCT04017546CI-TRIAL-00080670completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYC065 | Drug | Fadraciclib | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CYC065 and venetoclax
- description
- CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks.
- interventionNames
- Drug: CYC065
- Drug: Venetoclax
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- At the end of cycle 1 (each cycle is 28 days)
- description
- Number of patients who experience dose-limiting toxicity (DLT)
Secondary outcomes (2)
- measure
- Pharmacokinetic effect
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood * ECOG 0-2 * Adequate renal function * Adequate liver function * INR \<=1.2 in patients not receiving chronic anticoagulation * At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy * Agree to practice effective contraception Exclusion Criteria: * AML is of the subtype of APL or extramedullary myeloid tumor without bone marrow involvment * Known AML involvement in CNS that is symptomatic and active * Currently receiving radiotherapy, biological therapy, or any other investigational agents * Uncontrolled intercurrent illness * Pregnant or lactating * Known to be HIV-positive * Known active hepatitis B and/or hepatitis C infection
References
Publications (1)
- DERIVEDFrame S, Saladino C, MacKay C, Atrash B, Sheldrake P, McDonald E, Clarke PA, Workman P, Blake D, Zheleva D. Fadraciclib (CYC065), a novel CDK inhibitor, targets key pro-survival and oncogenic pathways in cancer. PLoS One. 2020 Jul 9;15(7):e0234103. doi: 10.1371/journal.pone.0234103. eCollection 2020. PMID 32645016