Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

Phase I, Uncontrolled, Open-label, Non-randomized Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Advanced, Refractory Solid Tumors

This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.

Study Overview

• Status: Completed
• Conditions: Tumors
• Intervention / Treatment: Drug: Regorafenib (BAY73-4506)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
    • Mitaka, Tokyo, Japan, 181-8611

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female Japanese patients >/= 18 years
• Histologically or cytologically confirmed solid tumors
• ECOG-PS 0 - 1
• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• Uncontrolled hypertension
• Patients with severe renal impairment or on dialysis
• Patients with seizure disorder requiring anticonvulsant medication
• Known or suspected allergy to the investigational agent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Regorafenib (BAY73-4506); The patients will be treated on Day 1 of the first week followed by 6 days off treatment (Cycle 0, single dosing period). After Cycle 0, the patients will be treated with BAY 73-4506 (160 mg once daily orally, 21 days on/ 7 days off schedule). Dose level : 160 mgDose level-1: 120 mgDose level-2: 60 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics	After 5 weeks (after Cycle 1).

Secondary Outcome Measures

Outcome Measure	Time Frame
Biomarker	At screening
Response rate	Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): April 26, 2010
• Study Completion (Actual): November 11, 2013

Study Registration Dates

• First Submitted: July 3, 2009
• First Submitted That Met QC Criteria: August 14, 2009
• First Posted (Estimate): August 17, 2009

Study Record Updates

• Last Update Posted (Actual): September 27, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Solid Tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 13172