CI

At a glance

ClinicalIndex Comparison Record
Phase 1Unknown· 60 target
Drug / intervention
SHR7390drug
Likely dose
SHR7390 0.125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02968485
NCT02968485Phase 1Unknown
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A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SHR7390 in Patients With Advanced Solid Tumors

Jiangsu HengRui Medicine Co., Ltd.·interventional·Posted Nov 18, 2016·Updated Jan 15, 2019

In Brief

A Phase 1 clinical trial evaluating SHR7390 for Solid Tumor. Targeting 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesChina
Collaborators--

Timeline

Phase 1UnknownOverdue
2017201820192020202120222023202420252026
First PostedNov 18, 2016
Enrollment StartNov 1, 2016
Primary CompletionApr 1, 2019
Study CompletionJul 1, 2019
TodayJul 1, 2026
Enrollment to primary: 2.4 yearsPosted 9.6 years ago

Interventions

SHR7390drug

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.