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A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer

NCT02507544 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-05-21

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) 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

  • Anthony W Tolcher, M.D., FRCP(C) · South Texas Accelerated Research Therapeutics, LLC (START)

  • Nehal Lakhani, M.D., Ph.D. · START Midwest

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-04-29
Completion
2019-05-20

Countries

  • United States

Study Locations

More Related Trials

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 NCT02507544 on ClinicalTrials.gov