A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body weight greater than or equal to (>=) 40 kilograms (kg)
Relapsed or refractory (R/R) acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 (NPM1), nucleoporin 98 (NUP98) or nucleoporin 214 (NUP214) gene alterations, and has exhausted, or is ineligible for available therapeutic options
Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1
Regular bowel movements (that is [i.e.], average production of at least one stool every 2 days)
Disqualifiers
Acute promyelocytic leukemia or diagnosis of Down syndrome associated leukemia, according to world health organization (WHO) 2016 criteria
Active central nervous system (CNS) disease
Recipient of solid organ transplant
Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to Grade 1 or less
Trial design
Design model
Single group
Treatments tested in this trial
14C-bleximenib
Drug14C-bleximenib will be administered orally.
bleximenib
DrugNon-radiolabeled bleximenib will be administered orally.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: BleximenibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Dose Excreted in Urine (feu)
Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.
Time frame
Up to Day 282
Percentage of Dose Excreted in Feces (fef)
Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.
Time frame
Up to Day 283
Amount Excreted in Urine (Aeu)
Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.
Time frame
Up to Day 284
Amount Excreted in Feces (Aef)
Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.
Time frame
Up to Day 28Secondary outcomes
1
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the study treatment. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Time frame
Up to 58 daysSponsors and contacts
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Source ClinicalTrials.gov