Clinical trial · Interventional
Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia
An Open Label, Multi-Center Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia With Neutropenia
- 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)
An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia with neutropenia. A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing. All patients will receive chemotherapy for their AML according to local clinical standard of care as well as antifungal prophylaxis. APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of chemotherapy
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 | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APX001 with Standard of Care anti-fungal agent | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- APX001 with Standard of Care Anti-fungal agent
- interventionNames
- Drug: APX001 with Standard of Care anti-fungal agent
Primary outcomes (1)
- measure
- Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0
- timeFrame
- One to forty-four days
Secondary outcomes (2)
- measure
- Area under the plasma concentration versus time curve (AUC)
- timeFrame
- One to forty-four days
- measure
- Peak Plasma Concentration (Cmax)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Key Inclusion Criteria: * Provision of written consent * Ages 18-75 inclusive, male or female * Diagnosis of Acute Myeloid Leukemia * Patients entering first induction treatment chemotherapy * Expected to be neutropenic (\<500 ANC/ul) for \>/= 10 days Key Exclusion Criteria: * Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months * Current fever (\> 38 degrees Celsius) * Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine
References
Publications (0)
Data not yet available