NCT00960258

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2010

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2013

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

July 3, 2009

Last Update Submit

September 26, 2017

Conditions

Tumors

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Biomarker

    At screening

  • Response rate

    Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Regorafenib (BAY73-4506)

Interventions

Regorafenib (BAY73-4506)DRUG

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

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Unknown Facility

Hidaka, Saitama, 350-1298, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0045, Japan

Location

Unknown Facility

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

regorafenib

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2009

First Posted

August 17, 2009

Study Start

July 1, 2009

Primary Completion

April 26, 2010

Study Completion

November 11, 2013

Last Updated

September 27, 2017

Record last verified: 2017-09

Locations

JP(4)