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First in Human Dose Escalation Study of Vactosertib (TEW-7197) in Subjects With Advanced Stage Solid Tumors

NCT02160106 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-05-09

No results posted yet for this study

Summary

The phase I dose escalation study will investigate the safety, tolerability, and pharmacokinetics of the TGF-β pathway inhibitor TEW 7197 in subjects with advanced, refractory solid tumors.

Conditions

  • Advanced Stage Solid Tumors

Interventions

DRUG

TEW-7197

Single daily doses by oral administration on Days 1, 2, 3, 4, 5, Days 8, 9, 10, 11, 12, Days 15, 16, 17, 18, 19 and Days 22, 23, 24, 25, 26 of each 28 day cycle. Starting dose is 30 mg, with escalation to 60 mg, and subsequent dose escalation using a modified Fibonacci algorithm.

Sponsors & Collaborators

  • National OncoVenture

    collaborator OTHER

  • MedPacto, Inc.

    lead INDUSTRY

Principal Investigators

  • Ilho Ha, PhD · MedPacto, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-29
Primary Completion
2018-07-31
Completion
2018-08-28

Countries

  • United States

Study Locations

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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 NCT02160106 on ClinicalTrials.gov