check_circleStudy Completed
Neoplasms
Bayer Identifier:
100561
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Effect of BAY 43-9006 (sorafenib) on cardiovascular safety parameters in cancer patients
Trial purpose
This is an open-label, non-randomized Phase I study of sorafenib 400 mg bid (2 x 200 mg tablets) in cancer patients. The primary objective of the study is to evaluate the effect of sorafenib on cardiovascular safety parameters. The secondary objectives are to evaluate the safety, pharmacokinetics, and anti-tumor activity of sorafenib in cancer patients
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
53Trial Dates
August 2005 - March 2008Phase
Phase 1Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dana-Farber Cancer Institute | Boston, 02115, United States |
Completed | Institute for Drug Development | San Antonio, 78229, United States |
Primary Outcome
- Effect of sorafenib on cardiovascular safety parametersdate_rangeTime Frame:up to 2 monthsenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Pharmacokineticsdate_rangeTime Frame:after 16 monthsenhanced_encryptionnoSafety Issue:
- Anti-tumor activitydate_rangeTime Frame:after 10 monthsenhanced_encryptionnoSafety Issue:
- Adverse Event Collectiondate_rangeTime Frame:after 11 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1