Clinical trial · Interventional
Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS
An Open-Label, Dose Escalation, Safety and Pharmacokinetic Study of CFI-400945 Fumarate Administered Orally to Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT03187288CI-TRIAL-00080090completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
This is a phase 1 study of investigational drug CFI-400945 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. The purpose of this phase 1 study is to see how safe and tolerable the study drug is and to determine the best dose (maximum tolerated dose or recommended phase 2 dose) that can be given in this patient population.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Refractory Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Relapsed Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CFI-400945 Fumarate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CFI-400945
- description
- CFI-400945 will be given by mouth at 64,96,128,160,192 or 224 mg/day, everyday until intolerable side effects or disease progression.
- interventionNames
- Drug: CFI-400945 Fumarate
Primary outcomes (3)
- measure
- Evaluation of the frequency and severity of treatment-emergent adverse events in patients
- timeFrame
- 5 years
- description
- This will be done to assess safety and tolerability of CFI-400945 fumarate
- measure
- Highest tolerated dose of CFI-400945 fumarate
- timeFrame
- 5 years
- description
- The Maximum Tolerated Dose MTD is defined as the highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Relapsed and/or refractory myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that meets certain criteria for prior treatments * Have acceptable circulating blasts count * Have clinically acceptable laboratory blood and urine test results * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Be able to swallow oral medications * Have a life expectancy of 3 months or more * Agree to use highly effective means of contraception during a defined period * Negative serum pregnancy test before the start of the study drugs * Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, provide a blood and bone marrow sample for genetic testing and agree to return for the required assessments Exclusion Criteria: * Have received cancer therapies within 14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug or have not recovered from toxicities from prior treatments * Not recovered from toxicities related to allogeneic transplant * Known active extramedullary central nervous system (CNS) AML * Secondary cancer needing therapy with exceptions * Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection * Known significant mental illness or other condition that may affect the ability to follow the requirements of the study * Have a chronic infection * Have uncontrolled severe hypertension * Have symptomatic congestive heart failure * Have active angina pectoris or recent myocardial infarction * Have chronic atrial fibrillation or unacceptable QTc * Have had major surgery within 21 days of starting therapy * Have additional uncontrolled serious medical or psychiatric illness * Have any medical condition that would affect taking the study drug * Receiving treatment with full dose warfarin * Receiving treatment with drugs not allowed in this study * Women who are pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.