Advanced Malignancies, Tumors
Conditions
Keywords
EPO, Patupilone, Solid Tumors
Brief summary
Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.
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
* Completion of the core study is required for participation in the extension. * 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 |
|---|---|
| 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 | at completion of the study |
| To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks | at completion of the study |
Countries
United States
Outcome results
None listed