Trial Condition(s):
Neoplasms
Phase I study of BAY73-4506 in Chinese patients with advanced, refractory solid tumors
Bayer Identifier:
14996
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This will be an uncontrolled, open-label, non-randomized, phase I study.
The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations National Cancer Center Singapore, Singapore, 169610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prince of Wales Hospital Shatin, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National University Hospital Singapore, Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Pharmacokinetics as measured by cmax and AUCTimeframe: Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21
- Adverse Event collectionTimeframe: every 1-2 weeks
Secondary Outcome
- Objective tumor response rateTimeframe: Every 8 weeks for the first 6 cycles, afterwards every 12 weeks
Additional Information
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