NCT02363439

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2014

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 13, 2017

Completed
Last Updated

January 9, 2018

Status Verified

December 1, 2017

Enrollment Period

2.1 years

First QC Date

November 19, 2014

Results QC Date

October 12, 2017

Last Update Submit

December 12, 2017

Conditions

Waldenstrom's Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

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

    During receipt of study treatment on the trial.

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed 24 weeks of treatment in Protocol 8400-401

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

bazlitoran

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Idera Medical Monitor
Organization
Idera Pharmaceuticals, Inc.
clinicaltrials@iderapharma.com
617-679-5500

Study Officials

  • Mark Cornfeld, MD, MPH

    Idera Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

February 16, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 9, 2018

Results First Posted

November 13, 2017

Record last verified: 2017-12