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NCT06150157 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
A Phase 1 study of Neoplasms, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT06150157: Recruiting Phase 1 study of Neoplasms, sponsored by Janssen Research & Development.
NCT06150157 is a Phase 1 study of Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 220 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06150157, a Phase 1 study of Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.
Primary Outcome
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. For US only: A DLT is any adverse event attributed to study treatment that meets the criteria for severity and duration and that occurs during the evaluation periods unless it can be incontrovertibly attributed to disease or other extraneous cause such as an accident.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Momelotinib
- DRUG JNJ-88549968
Study Locations (20)
Other
- Hopital Saint Louis - Paris
- CH LYON SUD - Hematology - Pierre-Bénite
- Universitaetsklinikum der RWTH Aachen - Aachen
- Charite Campus Benjamin Franklin - Berlin
- Med. Universitatsklinik Essen - Essen
- Medizinische Hochschule Hannover - Hanover
- Universitaetsklinikum Heidelberg - Heidelberg
- Universitaetsklinikum Regensburg - Regensburg
New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Medical Center - The Bronx
California
- City of Hope - Duarte
Colorado
- UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center - Aurora
Florida
- Moffit Cancer center - Tampa
Michigan
- University of Michigan - Ann Arbor
North Carolina
- Levine Cancer Institute - Charlotte
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2028-04-12 |
| Phase | Phase 1 |
What NCT06150157 shows while recruiting
NCT06150157 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Ruxolitinib is the first listed.
NCT06150157 names 20 study sites across 12 states, led by Other, New York, California.
Frequently Asked Questions
What is clinical trial NCT06150157 about?
NCT06150157 is a clinical study titled "A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms". The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose o...
What is the current status of trial NCT06150157?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2023-12-20. Estimated completion is 2028-04-12.
What conditions does trial NCT06150157 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT06150157?
The interventions under investigation include: Ruxolitinib (DRUG), Momelotinib (DRUG), JNJ-88549968 (DRUG).
Who is sponsoring clinical trial NCT06150157?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06150157 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06150157's enrollment target sits among peer trials
220 46th of 158 higher than 113 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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