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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Waldenstrom's Macroglobulinemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No