- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363439
Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401
December 12, 2017 updated by: Idera Pharmaceuticals, Inc.
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
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
|
IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
During receipt of study treatment on the trial.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mark Cornfeld, MD, MPH, Idera Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
November 19, 2014
First Submitted That Met QC Criteria
February 9, 2015
First Posted (Estimate)
February 16, 2015
Study Record Updates
Last Update Posted (Actual)
January 9, 2018
Last Update Submitted That Met QC Criteria
December 12, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Waldenstrom Macroglobulinemia
Other Study ID Numbers
- 8400-404
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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