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NCT03162536 · ClinicalTrials.gov registry record · Phase 1
A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)
A Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).
- Active
- Registry status
- Phase 1
- Development phase
- 190
- Enrollment target
- 10
- Study locations
NCT03162536: Active Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).
NCT03162536 is a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma that is active but no longer recruiting, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA). The registered enrollment target is 190 participants, roughly in line with the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target. The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03162536, a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 190 participants
- Enrollment target
- 10
- Study locations
Study Summary
This study aims to evaluate the safety, tolerability, pharmacodynamic, and pharmacokinetic (PK) of nemtabrutinib (formerly ARQ 531) tablets in selected participants with relapsed or refractory hematologic malignancies. No formal hypothesis testing will be performed for this study.
Primary Outcome
DLT is defined by the occurrence of any of the following treatment emergent adverse event (TEAE) unless unequivocally due to the underlying malignancy or an extraneous cause within the first 28 days of study treatment (for dose escalation only) and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Any Grade 5 TEAE, any Grade 3 nonhematological TEAE except alopecia, nausea, vomiting, diarrhea, and transient Grade 3 laboratory ab
Conditions Studied
Interventions
- DRUG Nemtabrutinib
Study Locations (10)
Arizona
- Mayo Clinic Hospital ( Site 0140) - Scottsdale
California
- UCLA Hematology & Oncology ( Site 0017) - Los Angeles
Colorado
- Colorado Blood Cancer Institute ( Site 0225) - Denver
Michigan
- University of Michigan ( Site 0018) - Ann Arbor
Minnesota
- Mayo Clinic - Rochester ( Site 0138) - Rochester
North Carolina
- Duke Cancer Center ( Site 0067) - Durham
Ohio
- The Ohio State University Wexner Medical Center ( Site 0056) - Columbus
Tennessee
- Tennessee Oncology, PLLC ( Site 0020) - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2026-09-18 |
| Phase | Phase 1 |
What the registry record for NCT03162536 still lists
NCT03162536 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target.
The record links to 9 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Nemtabrutinib is the first listed.
NCT03162536 lists 10 locations in 10 states (Arizona, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03162536 about?
NCT03162536 is a clinical study titled "A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)". This study aims to evaluate the safety, tolerability, pharmacodynamic, and pharmacokinetic (PK) of nemtabrutinib (formerly ARQ 531) tablets in selected participants with relapsed or refractory hematologic malignancies. No formal hypothesis testing will be performed for this study.
What is the current status of trial NCT03162536?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2017-06-26. Estimated completion is 2026-09-18.
What conditions does trial NCT03162536 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT03162536?
The interventions under investigation include: Nemtabrutinib (DRUG).
Who is sponsoring clinical trial NCT03162536?
This trial is sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03162536 being conducted?
This trial has 10 study locations across Arizona, California, Colorado, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03162536's enrollment target sits among peer trials
190 45th of 187 higher than 143 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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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