Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03573310
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2018-06-20
Brief Title:
A Study of JNJ-64619178 an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors NHL and Lower Risk MDS
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 1 First-in-Human Open-Label Study of the Safety Pharmacokinetics and Pharmacodynamics of JNJ-64619178 an Inhibitor of Protein Arginine Methyltransferase 5 PRMT5 in Subjects With Advanced Cancers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to identify the maximum tolerated dose MTD of JNJ-64619178 in participants with relapsedrefractory B cell non-Hodgkin lymphoma NHL or advanced solid tumors and also to identify the recommended Phase 2 doses RP2Ds of JNJ-64619178 for NHL and advanced solid tumors Part 1 and to confirm the tolerability of JNJ-64619178 in participants with lower risk myelodysplastic syndromes MDS Part 2
Detailed Description:
The study is designed to determine the maximum tolerated dose MTD of JNJ-64619178 and to select a doses and regimens that may be used in future clinical development Study evaluations will include safety pharmacokinetics biomarkers and efficacy evaluations Disease Assessments Adverse events will be evaluated throughout the study The study is divided into 4 periods a screening phase a pharmacokinetic run-in phase a treatment phase and a post treatment follow-up phase An end-of-treatment visit will be completed less than or equal 30 days 7 days after the last dose of study drug or prior to the start of a new anticancer therapy whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 64619178EDI1001 | OTHER | None | None |
| 2018-000067-87 | EUDRACT_NUMBER | Janssen Research Development LLC | None |