NCT02498665

A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

A Phase I Clinical Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Glioblastoma Multiforme
• Melanoma
• Non-Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Sarcoma
• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	DSP-7888 Dosing Emulsion	Dose escalation cohort: 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. MDS cohort 1: Patients will be intradermally administered of DSP-7888 at 10.5 mg every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks. MDS cohort 2: Patients will be intradermally administered of DSP-7888 at 10.5 mg every 2 weeks until Week 24, and then every 4 weeks.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-08-01
• Completion: 2018-09-01
• First posted: 2015-07-15
• Last updated: 2023-11-14

Locations

8 sites across 1 country: United States