Advanced Malignancies, Solid Tumors
Conditions
Keywords
EPO, Patupilone, Solid Tumors
Brief 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
Interventions
DRUGPatupilone
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. 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. 3. Adequate hematological laboratory parameters 4. No major impairment of renal or hepatic function 5. Female patients must have a negative serum pregnancy test at screening.
Exclusion criteria
1. Severe and/or uncontrolled medical disease; 2. Severe cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary artery disease; 3. Known diagnosis of human immunodeficiency virus (HIV) infection; 4. Presence of any other active or suspected acute or chronic uncontrolled infection; 5. Symptomatic brain metastases or leptomeningeal disease. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | one week |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be assessed by AEs, SAEs and out of range lab values. | every 6 weeks |
| Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity. | every 6 weeks |
Countries
United States
Outcome results
None listed