CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Metatinib Tromethaminedrug
Likely dose
Not stated in 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/NCT02004548
NCT02004548Phase 1Completed

A Phase I, Multiple Dose Escalation Clinical Trial of Metatinib Tromethamine Tablet in Patients With Advanced or Metastatic Solid Tumors

Jiangsu Simcere Pharmaceutical Co., Ltd.·interventional·Posted Dec 9, 2013·Updated Dec 29, 2015

In Brief

A Phase 1 clinical trial evaluating Metatinib Tromethamine for Advanced or Metastatic Solid Tumors. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters. Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD.

Study Details

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

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2013
Enrollment StartMay 1, 2013
Primary CompletionSep 1, 2015
Study CompletionDec 1, 2015
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 12.6 years ago

Interventions

Metatinib Tromethaminedrug