Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
- Registration Number
- NCT00448396
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patupilone Patupilone -
- Primary Outcome Measures
Name Time Method To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
- Secondary Outcome Measures
Name Time Method To evaluate the effects of patupilone on the pharmacodynamics of warfarin in patients with advanced malignancies. Safety and tolerability of patupilone when administered concomitantly with warfarin in patients with advanced malignancies will be assessed by AE's, SAE's and safety labs.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does Patupilone modulate CYP2C9/CYP3A4 activity affecting Warfarin's pharmacokinetics in advanced malignancies?
What are the comparative safety and efficacy of Patupilone-Warfarin interactions versus other microtubule inhibitors in cancer patients?
Which genetic biomarkers predict altered Warfarin metabolism during Patupilone co-administration in oncology?
What adverse events were observed in NCT00448396 when combining Patupilone with Warfarin and how were they managed?
Are there alternative anticoagulants with better safety profiles when combined with Patupilone in advanced cancer therapies?