A Study of DSP-0337 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile
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|ClinicalTrials.gov Identifier: NCT03416816|
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: DSP-0337||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0337 in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||May 15, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2020|
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.
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.
- Maximum tolerated dose by assessing dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ]Dose escalating cohort
- Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ]Dose escalating cohort
- Number of Patients with Adverse Events [ Time Frame: 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 [ Time Frame: 4 weeks ]For food effect, dose escalating cohort
- Urine excretion of napabucasin after DSP-0337 administration [ Time Frame: 24 hours ]Twenty four-hour urine will be collected and excretion of napabucasin will be evaluated.
- Objective response rate (ORR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- Overall survival [ Time Frame: 12 months ]Measured from the date of first dose to the date of death by any cause.
- Exploratory pharmacodynamic evaluation, including phosphorylated STAT3 (pSTAT3) expression level in patient-derived tumor tissue, as potential biomarkers [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416816
|Contact: Boston Biomedical, Inc.||email@example.com|
|United States, Indiana|
|Indiana University Health Melvin and Bren Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|Karmos Cancer Center||Recruiting|
|Detroit, Michigan, United States, 48201|
|United States, Texas|
|UT Heatlh San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|United States, Utah|
|Utah Cancer Specialist||Recruiting|
|West Jordan, Utah, United States, 84088|