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Brief Title: A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies
Official Title: A Phase I Clinical Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies
Study ID: NCT02498665
Brief Summary: This is a multicenter, open label, Phase 1 dose-escalation study of DSP-7888 Dosing Emulsion administered to adult patients with advanced malignancies. Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase. Once RP2D is determined from either the intradermal or subcutaneous group, an additional 40 patients evaluable for response may be enrolled as an expansion cohort at this dose and route of administration to confirm safety and tolerability. Separate from the dose-ascending cohort and RP2D expansion cohort described previously, and once the intradermal dose-ascending cohort is completed, up to 20 MDS patients who are refractory to treatment with hypomethylating agents (HMAs) will be enrolled into an MDS expansion cohort. Of these 20 MDS patients, one-half will receive DSP-7888 at 10.5 mg according to the modified schedule employed in Phase 1 (every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks; \[MDS Cohort 1\]). The other half of the MDS patients will receive DSP-7888 at 10.5 mg in an alternative dosing schedule where DSP-7888 is administered every 2 weeks until Week 24, after which it will be administered every 4 weeks (MDS Cohort 2).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USOR - Rocky Mountain Cancer Center, Denver, Colorado, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
Horizon Oncology Research, Lafayette, Indiana, United States
USOR - TX Oncology Austin, Austin, Texas, United States
USOR -TX Oncology Dallas, Dallas, Texas, United States
USOR - TX Oncology Tyler, Tyler, Texas, United States
USOR - VA Cancer Specialists, Fairfax, Virginia, United States
USOR - VA Oncology Associates, Norfolk, Virginia, United States