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Safety and Pharmacokinetic Study of TRX-818 in Asian Solid Tumor Patients

NCT02703298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-03-28

No results posted yet for this study

Summary

TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. The objectives of this study are to determine the safety profile of TRX-818 including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) in Asians and determine the recommended dose and regimen(s) to initiate Phase 2.

Conditions

Interventions

DRUG

TRX-818 capsules

Sponsors & Collaborators

  • TaiRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Wu-Chou Su, M.D · National Cheng-Kung University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-25
Primary Completion
2018-01-23
Completion
2018-05-03

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02703298 on ClinicalTrials.gov