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

Primary Purpose

Waldenstrom's Macroglobulinemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
Sponsored by
Idera Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenstrom's Macroglobulinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk

    Arm Description

    Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401

    Outcomes

    Primary Outcome Measures

    Number of Participants With Adverse Events
    Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia

    Secondary Outcome Measures

    Full Information

    First Posted
    November 19, 2014
    Last Updated
    December 12, 2017
    Sponsor
    Idera Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02363439
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Idera Pharmaceuticals, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Waldenstrom's Macroglobulinemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
    Arm Type
    Experimental
    Arm Description
    Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
    Intervention Type
    Drug
    Intervention Name(s)
    IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
    Intervention Description
    IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401
    Primary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events
    Description
    Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
    Time Frame
    During receipt of study treatment on the trial.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Cornfeld, MD, MPH
    Organizational Affiliation
    Idera Pharmaceuticals, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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