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Completed

NCT Number: NCT01096030

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

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shatin, N.T, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female Chinese subjects >/- 18 years
  • Advanced, histologically or cytologically confirmed solid tumors
  • Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable.
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1;
  • Adequate bone marrow, liver and renal function
  • Life expectancy of at least 3 months

Exclusion criteria

  • Unstable/uncontrolled cardiac disease
  • History of arterial or venous thrombotic or embolic events
  • Malabsorption condition
  • Severe renal impairment; persistent proteinuria >/= Grade 3
  • Symptomatic metastatic brain or meningeal tumors
  • Clinically significant bleeding >/=Grade 3 within 30 days before start of study medication.

Treatment and study plan

Regorafenib (Stivarga, BAY73-4506)

Drug

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

Primary outcomes

  1. Pharmacokinetics as measured by cmax and AUC

    Time frame: Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21

  2. Adverse Event collection

    Time frame: every 1-2 weeks

Secondary outcomes

  1. Objective tumor response rate

    Time frame: Every 8 weeks for the first 6 cycles, afterwards every 12 weeks

Other outcomes

  1. Exploratory biomarker analysis

    Time frame: Screening, Cycle 0 or 1

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 30, 2010
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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