Overview

This trial is active, not recruiting.

Condition waldenstrom's macroglobulinemia
Treatment imo-8400
Phase phase 1/phase 2
Sponsor Idera Pharmaceuticals, Inc.
Start date March 2014
End date September 2017
Trial size 31 participants
Trial identifier NCT02092909, 8400-401

Summary

Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the proliferation of cell populations responsible for the propagation of the disease.

United States California, Florida, Georgia, Minnesota, New York, Texas, and Washington
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
IMO-8400 at escalating dose levels by subcutaneous injection
imo-8400

Primary Outcomes

Measure
Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia
time frame: Duration of study

Secondary Outcomes

Measure
Assess the treatment effect
time frame: Duration of study
Identify an appropriate dose of IMO-8400
time frame: Duration of study
Characterize PK
time frame: Duration of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients must have a diagnosis of relapsed Waldenstrom's Macroglobulinemia. In addition to the above, key inclusion and exclusion criteria are listed below. Inclusion Criteria: 1. At least 18 years of age. 2. Agree to use contraception 3. Hemoglobin ≥ 7.5 g/dL, - Absolute neutrophil count ≥ 1.0 x 109/L (1000/mm3), - Platelets ≥ 50,000/μL Exclusion Criteria: 1. Is nursing or pregnant 2. Has BMI > 34.9 kg/m2. 3. Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg). 4. Receiving chronic systemic corticosteroid therapy > 20 mg of prednisone daily. 5. Being treated with other anti-cancer therapies (approved or investigational). 6. Has, at the initiation of study drug, received cytotoxic chemotherapy or a Bruton's tyrosine kinase (BTK)-inhibitor (e.g. ibrutinib) within the past 3 weeks or rituximab within the past 2 months 7. Has an active infection requiring systemic antibiotics. 8. Has had surgery requiring general anesthesia within 4 weeks of starting the study. 9. Has autoimmune cytopenia (anemia, thrombocytopenia, leukopenia). 10. Has heart failure of Class III or IV. 11. Has sensory or motor neuropathy limiting daily activities.

Additional Information

Official title Phase 1/2 Open-Label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
Description Eligible subjects will be enrolled and assigned to escalating dose cohorts. Treatment will be administered by subcutaneous injection.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Idera Pharmaceuticals, Inc..