Acute Lymphoblastic Leukemia, Acute Leukemias, Acute Myeloid Leukemia
Conditions
Brief 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).
Interventions
DRUG14C-bleximenib
14C-bleximenib will be administered orally.
DRUGbleximenib
Non-radiolabeled bleximenib will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 58 days | 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. |
Countries
United Kingdom
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed