A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced MalignanciesResearch Question:
What is the safety and tolerability of DSP-7888 Dosing Emulsion by assessing dose-limiting
Basic Study Information
Purpose:Location: University of Rochester Medical Center
This is a 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 (between the skin layers) or subcutaneously
(under the skin) 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 the highest dose with acceptable toxicity is determined from either the intradermal
or subcutaneous group, an additional 40 patients 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 expansion cohort described previously,
and once the intradermal dose-ascending cohort is completed, up to 20 myelodysplastic
syndrome (MDS) patients who are resistant 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 [Named
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 (Named MDS Cohort 2).
Study Reference #: IBRT17055
Lead Researcher (Principal Investigator)
Lead Researcher: Nimish Mohile
Study Contact InformationStudy Coordinator: Jennifer Serventi
Phone: (585) 276-3971
Additional Study Details
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