Phase 2 N=5 Treatment

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

Waldenstrom's Macroglobulinemia

Bottom Line

View on ClinicalTrials.gov: NCT02363439 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: Number of Participants With Adverse Events — 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Idera Pharmaceuticals, Inc.
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	4	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02363439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.