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

Phase 1

Terminated

• Conditions: Neoplasms
• Interventions: Drug: DSP-0337

• Registration Number: NCT03416816
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-05-15
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DSP-0337	DSP-0337	In Part 1 - Up to six dose levels will be investigated in dose-escalating cohorts to identify a maximum tolerated dose (MTD). An additional subset of patients will be treated to assess the effect of food intake on the PK of DSP-0337 administration at the MTD level. Once the recommended Phase 2 dose (RP2D) has been established, patients will be treated with the RP2D to explore preliminary antitumor activity and safety profile.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose by assessing dose-limiting toxicities (DLTs)	4 weeks	Dose escalating cohort
Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)	4 weeks	Dose escalating cohort

Secondary Outcome Measures

Name	Time	Method
Number of Patients with Adverse Events	12 months	Tolerability will be evaluated based on the adverse events (AEs) recorded at each contact with the patient, physical examinations, and the results of laboratory tests. Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Pharmacokinetics by assessing drug concentration in blood	4 weeks	For food effect, dose escalating cohort
Urine excretion of napabucasin after DSP-0337 administration	24 hours	Twenty four-hour urine will be collected and excretion of napabucasin will be evaluated.
Objective response rate (ORR)	6 months	Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1.
Time to progression (TTP)	6 months	Defined as the time from first dose to the earlier date of assessment of progression by RECIST v1.1.
Progression free survival (PFS)	12 months	Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v1.1.

Trial Locations

Locations (4)

Indiana University Health Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Karmos Cancer Center; 🇺🇸 Detroit, Michigan, United States

UT Heatlh San Antonio; 🇺🇸 San Antonio, Texas, United States

Utah Cancer Specialist; 🇺🇸 West Jordan, Utah, United States