check_circleStudy Completed

Tumors

Bayer Identifier:

13172

ClinicalTrials.gov Identifier:

NCT00960258

EudraCT Number:

Not Available

EU CT Number:

Not Available
Phase I study to investigate pharmacokinetics and safety of BAY73-4506 in Asian (Japanese) patients with solid tumors.

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

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

  • - 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.

Trial summary

Enrollment Goal
15
Trial Dates
July 2009 - November 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Mitaka, 181-8611, Japan
Completed
Chuo-ku, 104-0045, Japan
Completed
Kashiwa-shi, 277-8577, Japan
Completed
Hidaka, 350-1298, Japan

Primary Outcome

  • 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
    date_rangeTime Frame:
    After 5 weeks (after Cycle 1).
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    Safety Issue:
    yes

Secondary Outcome

  • Biomarker
    date_rangeTime Frame:
    At screening
    enhanced_encryption
    Safety Issue:
    no
  • Response rate
    date_rangeTime Frame:
    Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks
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    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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