Epacadostat, Cladribine and Cytarabine (ECC) in AML
NCT03491579 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2018-09-11
Summary
This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine chemotherapy in relapsed / refractory AML patients fit for intensive treatment
Conditions
- AML
- Relapse
Interventions
- DRUG
-
Epacadostat
Epacadostat orally two times daily (BID) for two cycles (28 days each) in combination with standard induction chemotherapy (Cladribine and Cytarabine)
- DRUG
-
Cladribine
Standard chemotherapy
- DRUG
-
Standard chemotherapy
Sponsors & Collaborators
-
Insel Gruppe AG, University Hospital Bern
lead OTHER
Principal Investigators
-
Thomas Pabst, Prof · Departement of Medical Oncology, University Hospital Berne
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-31
- Primary Completion
- 2019-09-30
- Completion
- 2019-10-31
Countries
- Switzerland
Study Locations
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