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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:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00960258
First received: July 3, 2009
Last updated: November 19, 2013
Last verified: November 2013

July 3, 2009
November 19, 2013
July 2009
April 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). ] [ Designated as safety issue: Yes ]
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). ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00960258 on ClinicalTrials.gov Archive Site
  • Biomarker [ Time Frame: At screening ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks ] [ Designated as safety issue: No ]
  • Biomaker [ Time Frame: At screening ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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
October 2013
April 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00960258
13172
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2013

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