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Phase I Study of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

NCT01096030 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2013-11-19

No results posted yet for this study

Summary

This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.

Conditions

  • Neoplasms

Interventions

DRUG

Regorafenib (Stivarga, BAY73-4506)

160 mg oral once daily BAY 73-4506 for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Hong Kong
  • Singapore

Study Locations

More Related Trials

Entities

Companies

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 NCT01096030 on ClinicalTrials.gov