Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies
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ClinicalTrials.gov Identifier: NCT00448396 |
Recruitment Status :
Completed
First Posted : March 16, 2007
Last Update Posted : November 19, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Malignancies | Drug: Patupilone | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Patupilone |
Drug: Patupilone |
- To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria
- Age ≥ 18 years of age
- Life expectancy ≥3 months
- Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist
- Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study
Exclusion criteria
- History of/or active bleeding disorders
- Known hypersensitivity to warfarin or related compounds
- The use of vitamin K
- Central lines that require anticoagulant maintenance
- The use of agents containing warfarin and heparin
- Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis Other protocol-defined inclusion/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448396
United States, Texas | |
San Antonio, Texas, United States |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00448396 |
Other Study ID Numbers: |
CEPO906A2120 |
First Posted: | March 16, 2007 Key Record Dates |
Last Update Posted: | November 19, 2009 |
Last Verified: | November 2009 |
Cancer EPO Patupilone Solid tumors Advanced malignancies |
Neoplasms Epothilone B Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |