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

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960258
• Other study ID #: 13172
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2009
• Last updated: September 26, 2017
• Start date: July 1, 2009
• Est. completion date: November 11, 2013

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 11, 2013
• Est. primary completion date: April 26, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biomarker		At screening
Secondary	Response rate		Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks

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