check_circleStudy Completed

Bayer Identifier:

11650

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2005-001198-81

EU CT Number:

Not Available
BAY73-4506, Phase I dose-escalation intermittent dosing

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • -

  • -

Trial summary

Enrollment Goal
76
Trial Dates
July 2005 - August 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Freiburg, 79106, Germany
Completed
Essen, 45147, Germany
Completed
Herne, 44625, Germany

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.
    date_rangeTime Frame:
    From start of study drug administration up to 30 days after study drug discontinuation

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
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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