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NCT04775745 · ClinicalTrials.gov registry record · Phase 1
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
A Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Newave Pharmaceutical.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 4
- Study locations
NCT04775745: Recruiting Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Newave Pharmaceutical.
NCT04775745 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma that is actively recruiting participants, run by Newave Pharmaceutical. The registered enrollment target is 60 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (72% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04775745, a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, is actively recruiting participants, sponsored by Newave Pharmaceutical.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.
Primary Outcome
When more than 1 DLT occurs in ≤ 6 subjects in a dosing cohort, dose escalation will be stopped and this dose level will be identified as the non-tolerated dose. Doses between the non-tolerated dose and the preceding lower dose, where ≤ 1 DLT occurred, may be explored to more precisely define the MTD.
Conditions Studied
Interventions
- DRUG LP-168
Study Locations (4)
Ohio
- University of Cincinnati - Cincinnati
- Ohio State University - Columbus
North Carolina
- Duke Univerisity - Durham
Utah
- Huntsman Cancer Institute, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-07-19 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04775745 shows while recruiting
NCT04775745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (72% lower).
The record links to 7 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which LP-168 is the first listed.
NCT04775745 reports a single indexed study location in Ohio, North Carolina, Utah.
Frequently Asked Questions
What is clinical trial NCT04775745 about?
NCT04775745 is a clinical study titled "Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.". This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.
What is the current status of trial NCT04775745?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-07-19. Estimated completion is 2027-12-31.
What conditions does trial NCT04775745 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia.
What interventions are being tested in trial NCT04775745?
The interventions under investigation include: LP-168 (DRUG).
Who is sponsoring clinical trial NCT04775745?
This trial is sponsored by Newave Pharmaceutical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04775745 being conducted?
This trial has 4 study locations across North Carolina, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diffuse Large B Cell Lymphoma
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 NCT04775745's enrollment target sits among peer trials
60 54th of 114 higher than 61 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma 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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