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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00960258
First Posted: August 17, 2009
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
July 3, 2009
August 17, 2009
September 27, 2017
July 1, 2009
April 26, 2010   (Final data collection date for primary outcome measure)
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 [ Time Frame: After 5 weeks (after Cycle 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 manageble and pharmacokinetics [ Time Frame: After 5 weeks (after Cycle 1). ]
Complete list of historical versions of study NCT00960258 on ClinicalTrials.gov Archive Site
  • Biomarker [ Time Frame: At screening ]
  • Response rate [ Time Frame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks ]
  • Biomaker [ Time Frame: At screening ]
  • Response rate [ Time Frame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tumors
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
Experimental: Arm 1
Intervention: Drug: Regorafenib (BAY73-4506)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 11, 2013
April 26, 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00960258
13172
Yes
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP