Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401

An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.

Completed

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Key information

Conditions

Waldenstrom's Macroglobulinemia Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Completed 24 weeks of treatment in Protocol 8400-401

Exclusion criteria

Grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under Protocol 8400-401.
Has evidence of disease progression under Protocol 8400-401.
Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.

Treatment and study plan

IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly

Drug

IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401

Primary outcomes

Number of Participants With Adverse Events

Time frame: During receipt of study treatment on the trial.

Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia

Sponsors and collaborators

Lead sponsor

Idera Pharmaceuticals, Inc.

Industry

Registry information

Official study title

An Extension Study to Evaluate the Long-Term Safety, Tolerability, and Clinical Activity of IMO-8400 in Patients With Relapsed or Refractory Waldenström's Macroglobulinemia Who Completed Study 8400-401

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Feb 16, 2015
Registry last updated: Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed