14C-bleximenib: 14C-bleximenib will be administered orally.
bleximenib: Non-radiolabeled bleximenib will be administered orally.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
* 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)
* A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
Exclusion criteria:
* 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
* Major surgery (e.g., requiring general anesthesia) within 2 weeks prior to first dose of study treatment or has not recovered from surgery or has major surgery planned during the time the participant is receiving study treatment
Primary outcome measure(s)
Percentage of Dose Excreted in Urine (feu) — Up to Day 28 Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.
Percentage of Dose Excreted in Feces (fef) — Up to Day 28 Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.
Amount Excreted in Urine (Aeu) — Up to Day 28 Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.
Amount Excreted in Feces (Aef) — Up to Day 28 Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) — Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days) AUC0-t in whole blood and plasma will be reported.
Maximum Observed Concentration (Cmax) — Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days) Maximum observed concentration in whole blood and plasma will be determined.
Trial sites (1)
Facility
City
Region
Status
The Christie NHS Foundation Trust Christie Hospital
Manchester
United Kingdom
Recruiting
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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