Clinical trial · Interventional
A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
NCT03884829CI-TRIAL-00080894terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Switch to oral formulation of CYC140 (plogosertib)
Summary
Brief summary (as posted)
A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL, Adult | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
| CLL, Refractory | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| CML, Refractory | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.78 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYC140 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CYC140 single agent
- description
- CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle
- interventionNames
- Drug: CYC140
Primary outcomes (1)
- measure
- Number of Patients who experience dose -limiting toxicity (DLT)
- timeFrame
- At end of cycle 1 (each cycle is 21 days)
Secondary outcomes (1)
- measure
- Pharmacokinetic measurement - area under the curve (AUC)
- timeFrame
- At the end of cycle 1 (each cycle is 21 days)
- description
- plasma drug exposure area under the curve (AUC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of relapsed or refractory advanced leukemias or MDS * ECOG 0-2 * Adequate renal function * Adequate liver function * ≥ 2 weeks from prior chemotherapy, radiation therapy or major surgery * ≥ 4 weeks from other investigational anticancer therapy * Agree to practice effective contraception Exclusion Criteria: * Known CNS involvement by leukemia * 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 (0)
Data not yet available
No reference posted for this study.