stop_circleTerminated/Withdrawn
Leukemia
Bayer Identifier:
19420
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to investigate BAY2402234, a dihydroorotate dehydrogenase (DHODH) inhibitor, in myeloid malignancies
Trial purpose
The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).
The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).
The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
40Trial Dates
March 2018 - January 2021Phase
Phase 1Could I Receive a placebo
NoProducts
BAY2402234Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Institut Gustave Roussy | VILLEJUIF CEDEX, 94805, France |
Completed | Montefiore Medical Center | Bronx, 10467-2490, United States |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Completed | Thomas Jefferson University | Philadelphia, 19107, United States |
Completed | Vanderbilt University Medical Center | Nashville, 37232, United States |
Primary Outcome
- Maximum tolerated dose (MTD)The MTD was defined as the maximum dose administered during Cycle 1 at which the estimated dose-limiting toxicity (DLT) probability is closest to 30%.date_rangeTime Frame:Up to 42 days after the first dose
- Number of subjects with DLTsA dose-limiting toxicity (DLT) was defined as any of the events that are clearly unrelated to underlying disease and occurring at any particular dose level during the first 28 days (i.e. Cycle 1) of treatment for non-hematological DLTs, or 42 days after the start of treatment, in the absence of active disease (i.e. < 5% blasts in bone marrow and absence of leukemic blasts in peripheral blood) for hematological DLTs. The National Cancer Institute Common Terminology Criteria for Adverse Events Version (CTCAE) v4.03 will be used to assess toxicities.date_rangeTime Frame:Up to 42 days after the first dose
- AUC(0-24) (area under the concentration versus time curve from time zero to 24 hours) after single dose on Cycle 1 Day 1 (C1D1)date_rangeTime Frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after dose administration at C1D1
- Cmax (maximum observed drug concentration in plasma after single dose administration) on C1D1date_rangeTime Frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours (QD cohorts=until 24 hours; BID cohort=until 12 hours) after dose administration at C1D1
- AUC(0-24)md (AUC(0-24) after multiple dose) on Cycle 1 Day 15 (C1D15)date_rangeTime Frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours after dose administration at C1D15
- Cmax,md (Cmax after multiple dose) on C1D15date_rangeTime Frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours (QD cohorts=until 24 hours; BID cohort=until 12 hours) after dose administration at C1D1
- Number of subjects with Treatment Emergent Adverse Events (TEAEs)An AE was any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study.date_rangeTime Frame:From first application of study intervention up to 30 days after end of treatment
Secondary Outcome
- Number of acute myeloid leukemia (AML) patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)date_rangeTime Frame:Up to 6 months on average
- Number of myelodysplastic syndrome (MDS) patients with hematologic improvement (erythroid response, platelet response, and neutrophil response)date_rangeTime Frame:Every month until disease progression or patient was withdrawn from study, up to 6 months on average
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Single Group AssignmentTrial Arms
3