Brief Title
Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401
Official 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
Brief Summary
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
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 Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Adverse Events
Condition
Waldenstrom's Macroglobulinemia
Intervention
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
Study Arms / Comparison Groups
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
Description: Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
5
Start Date
November 2014
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mark Cornfeld, MD, MPH, ,
Administrative Informations
NCT ID
NCT02363439
Organization ID
8400-404
Responsible Party
Sponsor
Study Sponsor
Idera Pharmaceuticals, Inc.
Study Sponsor
Mark Cornfeld, MD, MPH, Study Director, Idera Pharmaceuticals, Inc.
Verification Date
December 2017