Trial Condition(s):
N/A
BAY73-4506, Phase I dose-escalation intermittent dosing
Bayer Identifier:
11650
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To define the safety profile, pharmacokinetics, maximum tolerated dose, and recommended Phase II dose of regorafenib administered orally as a single agent in subjects with advanced malignancies
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Freiburg, Germany, 79106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45147 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Herne, Germany, 44625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open label, Phase I study to determine the safety, tolerability, maximum tolerated dose, pharmacokinetics, and biomarker status of BAY 73-4506 in patients with advanced malignancies
Trial Type:
Interventional
Intervention Type:
N/A
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
N/A
Primary Outcome
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and another medical important serious event as judged by investigator. AE/SAEs that started or worsened after study drug treatment up to 30 days after study drug discontinuation were recorded as TEAE/TESAEs.Timeframe: From start of study drug administration up to 30 days after study drug discontinuation
Additional Information
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