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

Idera Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Waldenstrom's Macroglobulinemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02363439

8400-404

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

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