Status:
COMPLETED
Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia
Lead Sponsor:
Basilea Pharmaceutica
Collaborating Sponsors:
The Clinical Trials Centre Cologne
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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....
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03333005
Start Date
November 27 2017
End Date
October 26 2018
Last Update
May 17 2024
Active Locations (3)
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1
University of Cologne, Center for Integrated Oncology (CIO)
Cologne, Germany, 50931
2
Johannes Gutenberg, University of Mainz
Mainz, Germany, 55131
3
University of Munich, Grosshadern Campus
Munich, Germany, 81377