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Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors


Inclusion Criteria:



- Male or female Chinese subjects >/- 18 years

- Advanced, histologically or cytologically confirmed solid tumors

- Subjects malignancies must be refractory to standard treatment or have no standard
therapy available, or the subject actively refused any treatment that would be
regarded standard, and/or if, in the judgment of the investigator or his/her
designated associate(s), experimental treatment is clinically and ethically
acceptable.

- Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1;

- Adequate bone marrow, liver and renal function

- Life expectancy of at least 3 months

Exclusion Criteria:

- Unstable/uncontrolled cardiac disease

- History of arterial or venous thrombotic or embolic events

- Malabsorption condition

- Severe renal impairment; persistent proteinuria >/= Grade 3

- Symptomatic metastatic brain or meningeal tumors

- Clinically significant bleeding >/=Grade 3 within 30 days before start of study
medication.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics as measured by cmax and AUC

Outcome Time Frame:

Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Singapore: Health Sciences Authority

Study ID:

14996

NCT ID:

NCT01096030

Start Date:

July 2010

Completion Date:

November 2012

Related Keywords:

  • Neoplasms
  • Regorafenib
  • Advanced
  • Refractory solid tumors
  • Neoplasms

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