Epacadostat, Cladribine and Cytarabine (ECC) in AML (ECC)
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|ClinicalTrials.gov Identifier: NCT03491579|
Recruitment Status : Withdrawn (IMP will not be further developed)
First Posted : April 9, 2018
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|AML Relapse||Drug: Epacadostat Drug: Cladribine Drug: Cytarabine||Phase 1|
Background and Rationale:
Epacadostat (INCB024360) is an Inhibitor of Indoleamine 2,3- dioxygenase 1 (IDO1). Indoleamine 2,3- dioxygenase 1 (IDO1) is a 403 amino acid cytosolic haem enzyme encoded by the INDO gene on human chromosome 8p22. IDO1 is responsible for the catabolism of the essential amino acid tryptophan (trp) to kynurenine (kyn) within immune cells and a subset of tumor cells resulting in inhibition of antitumor cell-mediated immune responses. Increased IDO activity correlates with lower CR rates and shorter OS in AML.
The primary objective is to determine 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
Phase I part will last from 3 to 18 months (permitting the enrolment of minimum of 3 and a maximum of 24 patients).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Epacadostat With Cladribine and Cytarabine (ECC) in Relapsed / Refractory AML Patients Fit for Intensive Chemotherapy; a Phase I Study.|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Dosis finding
Epacadostat is given for 2 cycles of 28 days at a dose according to the titration design together with standard chemotherapy (Cladribine and Cytarabine)
Epacadostat orally two times daily (BID) for two cycles (28 days each) in combination with standard induction chemotherapy (Cladribine and Cytarabine)
- Dose finding [ Time Frame: 30 days ]To determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat
- Rate of morphologic complete remission (CR) [ Time Frame: 60 days ]Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0G/L (1000/μL); platelet count > 100 x G/L (100.000/μL); independence of red cell transfusions.
- Adverse events [ Time Frame: 100 days ]Number of patients experiencing toxicity (Adverse Events)
- Overall survival [ Time Frame: 12 months ]Number of patients alive after 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491579
|Departement of Medical Oncology, University Hospital Berne|
|Berne, Switzerland, 3010|
|Study Chair:||Thomas Pabst, Prof||Departement of Medical Oncology, University Hospital Berne|