Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2017 |
| Start Date: | March 2014 |
| End Date: | November 2017 |
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
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.
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.
Eligible subjects will be enrolled and assigned to escalating dose cohorts. Treatment will be
administered by subcutaneous injection.
administered by subcutaneous injection.
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.
We found this trial at
10
sites
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Jacksonville, Florida 32216
Principal Investigator: Asher A. Chanan-Khan, MD
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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