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


Active: No
Cancer Type: Lymphoma
Non-Hodgkin Lymphoma
NCT ID: NCT02594384
Trial Phases: Phase I Protocol IDs: LAM-002A-NHL-CLN01 (primary)
NCI-2016-00527
Eligibility: 18 and over, Male and Female Study Type: Biomarker/Laboratory analysis
Treatment
Study Sponsor: Lam Therapeutics Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT02594384

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) and

preliminary activity will be evaluated.

Objectives

LAM-002A is supplied as 25 mg capsules and will be administered twice daily (BID) by mouth

with a cycle length of 28 days. Patients will be advised to take the doses at the same time

each day, approximately 12 hours apart on an empty stomach (no food within 2 hours prior to

dose, or within 2 hours after dose).

A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The MTD is defined

as the highest dose at which no more than 1 of 6 patients (i.e., < 33%) experiences a

dose-limiting toxicity (DLT) in the dose cohort.

Once the dose and schedule are established, additional patients will be treated to better

characterize the safety, tolerability, preliminary anti-tumor activity, PK and

pharmacodynamics of the study drug.