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| ID | Type | Description | Link |
|---|---|---|---|
| 75276617ALE1006 | Other Identifier | Janssen Research & Development, LLC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bleximenib | Experimental | Participants will receive a single oral dose of 14C-bleximenib on Cycle 1 Day 1. The recommended Phase 2 dose (RP2D) of bleximenib will start on Cycle 1 Day 2 with non-radiolabeled bleximenib and will continue until the end of Cycle 1 (cycle duration=28 days), with subsequent roll-over for eligible participants to 75276617ALE1001 (NCT04811560) for continued non-radiolabeled bleximenib administration as appropriate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-bleximenib | Drug | 14C-bleximenib will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Dose Excreted in Urine (feu) | Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported. | Up to Day 28 |
| Percentage of Dose Excreted in Feces (fef) | Total amount excreted into the feces expressed as a percentage of the administered dose will be reported. | Up to Day 28 |
| Amount Excreted in Urine (Aeu) | Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported. | Up to Day 28 |
| Amount Excreted in Feces (Aef) | Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported. | Up to Day 28 |
| Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) | AUC0-t in whole blood and plasma will be reported. | Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days) |
| Maximum Observed Concentration (Cmax) | Maximum observed concentration in whole blood and plasma will be determined. | Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christie NHS Foundation Trust Christie Hospital | Recruiting | Manchester | M20 4BX | United Kingdom |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| bleximenib | Drug | Non-radiolabeled bleximenib will be administered orally. |
|
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| Up to 58 days |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |