NCT03416816

A Study of DSP-0337 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile

A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0337 in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open label, multi-center study of orally administered DSP-0337 in adult subjects with advance solid tumors that are refractory to standard treatment, or for whom no effective therapy exists.

Detailed description

The study is comprised of two parts: an initial dose escalation phase utilizing a 3 + 3 design to determine maximum tolerated dose followed by a dose expansion cohort in approximately 30 additional subjects. Study participants will initially receive DSP-0337 orally for 28 days (one cycle of treatment). If clinical benefit is seen, treatment can continue until disease progression.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	DSP-0337	DSP-0337 will be administered at the following doses in dose-escalation cohorts, maximum tolerated dose (MTD) for food effect, and recommended phase 2 dose (RP2D) for dose-expansion cohort. Dose 1: 200 mg once daily, Dose 2: 200 mg twice daily, Dose 3: 400 mg twice daily, Dose 4: 600 mg twice daily, Dose 5: 800 mg twice daily, Dose 6: 1000 mg twice daily.

Timeline

• Start date: 2018-05-15
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2018-01-31
• Last updated: 2023-11-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study