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

Waldenstrom's Macroglobulinemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363439
• Other study ID #: 8400-404
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 19, 2014
• Last updated: December 12, 2017
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: Idera Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia
• Waldenstrom's Macroglobulinemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Idera Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.