Clinical trial · Interventional
Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML
A Dose-escalated Phase Ⅰ Trial to Assess the Tolerance and Pharmacokinetics of Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML Patient
NCT04402723CI-TRIAL-00062431terminatedPhase 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): Corporate policy adjustments
Summary
Brief summary (as posted)
This phase Ⅰ study of Donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess safety and pharmacokinetics in patients with Relapsed AML.
Conditions
Conditions (1)
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 (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Donafenib, 0.2g
- description
- Donafenib,0.2g,bid,Combination with Cytarabine and Daunorubicin.
- interventionNames
- Drug: Donafenib
- type
- EXPERIMENTAL
- label
- Donafenib,0.3g
- description
- Donafenib,0.3g,bid,Combination with Cytarabine and Daunorubicin
- interventionNames
- Drug: Donafenib
Primary outcomes (1)
- measure
- Safety(including the type, severity and frequency of AE)
- timeFrame
- through study completion, an average of 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML) . * Patients with diagnosed Relapsed AML according to Chinese Guidelines for the Diagnosis and Treatment of Acute Myeloid Leukemia. * relapse after 6 months of an morphological remission. * Age ≥ 18 and ≤ 55 years. * BMI ≥ 18 and ≤27. * Informed consent, personally signed and dated to participate in the study. * ECOG performance status of 0-1. * Life expectancy of at least 12 weeks. * Total serum bilirubin ≤1.5×ULN. * Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5×ULN. * Serum creatinine ≤1.5×ULN. * glomerular filtration rate ≥60 mL/min, as calculated with the Cockcroft-Gault formula. * alkaline phosphatase ≤1.5×ULN. * urine protein ≤1+, or Urine protein was quantified for 24h ≤0.5g. * INR/PTT \<1.5×ULN. Exclusion Criteria: * Patients who are not eligible for standard chemotherapy as per discretion of the treating physician. * Patients who have been treated with bone marrow transplantation. * Central nervous system manifestation of AML. * Cardiac disease: heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). * Patients who have thrombosis events within 6 months prior to study entry is permitted. * Pregnancy or breastfeed. * Chronic pulmonary disease with relevant hypoxia. * Patients undergoing dialysis. * Known HIV and/or hepatitis C infection. * Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy. * Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders. * Blood pressure (BP) higher than systolic 140 mmHg and/or diastolic 90 mmHg after best treatment. * Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance of the protocol. * Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry is permitted. * Serious, non-healing wound, ulcer or bone fracture. * Infection need antibiotic treatment. * Cumulative therapeutic dose of Daunorubicin more than 300mg/m2. * Concurrent malignancies other than AML. * History of organ allograft. * Allergy to study medication or excipients in study medication.
References
Publications (0)
Data not yet available
No reference posted for this study.