NCT02968485

Phase I Study of SHR7390 in Patients With Advanced Solid Tumors

A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SHR7390 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This aim of study to assess the safety and tolerability of SHR7390 and to define the maximum tolerated dose (MTD) of SHR7390 in the patients with advanced solid tumors. To evaluate the pharmacokinetics of SHR7390 in patients with advanced solid tumors. To study the effects of food on the pharmacokinetic parameters of SHR7390. To assess the antitumor activity of SHR7390 in patients with advanced solid tumors preliminarily and recommend reasonable dosage regimen for the follow-up clinical trial.

Detailed description

This is an open-label, dose escalation study of repeated doses of SHR7390 in the patients with advanced solid tumors that have no targeted agent as standard of therapy. A study cycle is defined as SHR7390 administered once daily orally for 28 days. Dose limiting toxicities (DLT) will be assessed in the first cycle of treatment. the trial is dose escalation and is designed by Accelerated Titration Designs during initial accelerated phase. when the significant toxicity or DLT is observed in any course of treatment,the accelerated titration trial terminates and subsequent cohort sizes and dose escalation are a conventional design of 3+3 patients. If one adverse event （AE） meets dose limiting toxicity (DLT) criteria at a given dose, 3 additional patients will be enrolled in this dose cohort. If 2 DLTs are determined at a given dose level, this dose will be designated as the MTD. Additional patients will be enrolled for PK evaluations at different dose levels based on preliminary safety and tolerability. Multiple blood samples at designated time points will be collected for PK evaluations. The safety, tolerability and AEs will be closely monitored throughout the study duration. The preliminary effectiveness and clinical benefits of SHR7390 will be evaluated as a single agent. The evaluation of the effects of a high-fat, high-calorie meal on the single-dose pharmacokinetics (PK) of SHR7390.The design to assess food-effect is a randomized, balanced, 2-treatment(fed vs. fasted), separated by an adequate wash-out period.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	SHR7390	SHR7390 is provided as white, film-coated,immediate release tablets containing SHR7390 at dosage strengths of 0.125 mg and 0.5 mg. Multiple tablets of SHR7390 will be administered daily to achieve targeted doses of SHR7390: 0.25 mg-4 mg. Tablets will be orally administered with 240 ml water, once daily, 2 hours after a meal.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-04-01
• Completion: 2019-07-01
• First posted: 2016-11-18
• Last updated: 2019-01-15

Locations

1 site across 1 country: China