A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma
NCT02594384 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2024-08-22
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.
Conditions
- Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic
Interventions
- DRUG
-
LAM-002A
25 mg capsules or 50 mg capsules
- DRUG
-
375 mg/m2 by vein
- DRUG
-
1200 mg by vein
Sponsors & Collaborators
-
OrphAI Therapeutics
lead INDUSTRY
Principal Investigators
-
Langdon Miller, MD · AI Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2020-03-09
- Completion
- 2023-03-30
Countries
- United States
Study Locations
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