Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects — NHL  

Non-Hodgkin Lymphoma Clinical Trial

Official title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)

Status Terminated

Clinical Trial Summary

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with Refractory Non-Hodgkin Lymphoma (NHL)

Clinical Trial Description

This open-label, non-randomized, first-in-human Phase 1 study involves two stages:

In the Dose-Escalation Stage, ascending dose cohorts will be treated in 2 periods until the maximum tolerated dose is identified. In Period 1, subjects will receive 2 doses of IGN002 administered weekly. In Period 2, subjects will receive up to 24 additional doses of IGN002 administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the identified maximum tolerated dose administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

• NCT number: NCT02519270
• Study type: Interventional
• Source: Spectrum Pharmaceuticals, Inc
• Status: Terminated
• Phase: Phase 1
• Start date: May 1, 2016
• Completion date: May 4, 2018