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NCT02594384 · ClinicalTrials.gov registry record · Phase 1
A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma
A Phase 1 study, sponsored by OrphAI Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT02594384: Completed Phase 1 study, sponsored by OrphAI Therapeutics.
NCT02594384 is a Phase 1 study that has completed, run by OrphAI Therapeutics. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02594384, a Phase 1 study, has completed, sponsored by OrphAI Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.
Primary Outcome
MTD was determined by testing increasing doses up to 125 mg twice a day or 75 mg three times a day orally on dose escalation cohorts with 3 to 6 participants each. In the dose escalation, the cohort sizes of 3 to 6 subjects allow evaluation of regimen safety using a standard definition of MTD (ie, the highest starting dose associated with DLT in \<33% of subjects during the first cycle of therapy) when administered continuously (daily administration) and then when administered intermittently (re
Interventions
- DRUG Atezolizumab
- DRUG Rituximab
- DRUG LAM-002A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-10 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 1 |
What the finished NCT02594384 record still lists
NCT02594384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Atezolizumab is the first listed.
NCT02594384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02594384 about?
NCT02594384 is a clinical study titled "A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma". This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.
What is the current status of trial NCT02594384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2015-10. Estimated completion is 2023-03-30.
What interventions are being tested in trial NCT02594384?
The interventions under investigation include: Atezolizumab (DRUG), Rituximab (DRUG), LAM-002A (DRUG).
Who is sponsoring clinical trial NCT02594384?
This trial is sponsored by OrphAI Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02594384's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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