check_circleStudy Completed

Neoplasms

Bayer Identifier:

14996

ClinicalTrials.gov Identifier:

NCT01096030

EudraCT Number:

Not Available

EU CT Number:

Not Available
Phase I study of BAY73-4506 in Chinese patients with advanced, refractory solid tumors

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 99 Years

  • - 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

  • - 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.

Trial summary

Enrollment Goal
33
Trial Dates
July 2010 - November 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
National Cancer CenterSingapore, 169610, Singapore
Completed
Queen Mary HospitalHong Kong, Hong Kong
Completed
Prince of Wales HospitalShatin, Hong Kong
Completed
National University HospitalSingapore, 119228, Singapore

Primary Outcome

  • Pharmacokinetics as measured by cmax and AUC
    date_rangeTime Frame:
    Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21
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    Safety Issue:
    no
  • Adverse Event collection
    date_rangeTime Frame:
    every 1-2 weeks
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    Safety Issue:
    yes

Secondary Outcome

  • Objective tumor response rate
    date_rangeTime Frame:
    Every 8 weeks for the first 6 cycles, afterwards every 12 weeks
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    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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