Acute Myeloid Leukemia
Conditions
Brief summary
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
Interventions
DRUGAPX001 with Standard of Care anti-fungal agent
safety assessment
Sponsors
The Clinical Trials Centre Cologne
Basilea Pharmaceutica
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The first 10 patients enrolled will be administered IV APX001. The second 10 patients enrolled will be administered oral APX001
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0 | One to forty-four days |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) | One to forty-four days |
| Peak Plasma Concentration (Cmax) | One to forty-four days |
Countries
Germany
Outcome results
None listed