CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 62 enrolled
Drug / intervention
LAM-002A +2 moredrug
Likely dose
LAM-002A 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02594384
NCT02594384Phase 1Completed

A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A (Apilimod Dimesylate Capsules) Administered Orally in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

OrphAI Therapeutics·interventional·Posted Nov 3, 2015·Updated Aug 22, 2024

In Brief

A Phase 1 clinical trial evaluating LAM-002A, Rituximab, and 1 other intervention for Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic. Completed, enrolled 62 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 3, 2015
Enrollment StartOct 1, 2015
Primary CompletionMar 9, 2020
Study CompletionMar 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 10.7 years ago

Interventions

LAM-002Adrug

25 mg capsules or 50 mg capsules

Rituximabdrug

375 mg/m2 by vein

Atezolizumabdrug

1200 mg by vein