Advanced Malignancies, Tumors
Conditions
Keywords
EPO, Patupilone, Solid Tumors
Brief summary
This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age 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; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work. * Life expectancy of 3 months or more * Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist
Exclusion criteria
* Severe and/or uncontrolled medical disease * Known diagnosis of human immunodeficiency virus (HIV) infection * Presence of any other active or suspected acute or chronic uncontrolled infection * Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease * History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite | After completion of the study (approximately 6 weeks from treatment) |
| To determine the maximum tolerated dose of patupilone in patients with hepatic impairment | After completion of the study (approximately 6 weeks from treatment) |
Secondary
| Measure | Time frame |
|---|---|
| To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics | After completion of the study (approximately 6 weeks from treatment) |
| Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values | After completion of the study (approximately 6 weeks from treatment) |
| To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks | After completion of the study (approximately 6 weeks from treatment) |
Countries
United States
Outcome results
None listed