CompletedPhase 1

Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.

United States5 participantsStarted 2006-08

Plain-language summary

The main purpose of this study is to characterize the distribution, metabolism, and elimination (ADME) of Patupilone after a single intravenous administration in patients with advanced solid tumor malignancies

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 years or older
✓. World Health Organization (WHO) Performance Status Score of: 0- you are fully active and more or less as you were before your illness, 1 - you cannot carry out heavy physical work, but can do anything else.
✓. Adequate hematological laboratory parameters
✓. No major impairment of renal or hepatic function
✓. Female patients must have a negative serum pregnancy test at screening.

Exclusion criteria

✕. Severe and/or uncontrolled medical disease;
✕. Severe cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary artery disease;
✕. Known diagnosis of human immunodeficiency virus (HIV) infection;
✕. Presence of any other active or suspected acute or chronic uncontrolled infection;
✕. Symptomatic brain metastases or leptomeningeal disease.

What they're measuring

To characterize the pharmacokinetic profile of patupilone including any potential metabolite(s) in blood/plasma as well as the total radioactivity in blood and plasma.

Timeframe: one week

Trial details

NCT IDNCT00426140

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-11

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