Spots Global Cancer Trial Database for Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
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Trial Identification
Brief Title: Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
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
Study ID: NCT02092909
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: Eligible subjects will be enrolled and assigned to escalating dose cohorts. Treatment will be administered by subcutaneous injection.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Centers of Excellence, Fayetteville, Arkansas, United States
UCLA, Los Angeles, California, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Emory Winship Cancer Institute, Atlanta, Georgia, United States
Horizon BioAdvance, Lafayette, Indiana, United States
Mayo Clinic, Rochester, Minnesota, United States
Hackensack University, Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Contact Details
Name: Mark Cornfeld, MD, MPH
Affiliation: Idera Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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