At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 5 enrolled
Drug / intervention
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weeklydrug
Likely dose
IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weeklyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly for Waldenstrom's Macroglobulinemia. Completed, enrolled 5 participants.
Detailed Summary
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenstrom's Macroglobulinemia
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedFeb 2015
Primary CompletionDec 2016
TodayJul 2026
First PostedFeb 16, 2015
Enrollment StartNov 1, 2014
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.4 years ago
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