Advanced Solid Tumors
Conditions
Keywords
Gimatecan, topoisomerase I inhibitor, advanced solid tumors
Brief summary
This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.
Interventions
DRUGGimatecan
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists. * Life expectancy of at least 3 months * Adequate hematological parameters * No major impairment of renal and hepatic function
Exclusion criteria
* Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption. * Patients who have received any investigational compound within the past 28 days. * Patients with other antineoplastic therapy within the last 28 days. * Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection * Patients with a history of allergies to the camptothecin family drug. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated Maximum Tolerated Dose of gimatecan | 1.8 years |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by adverse events | 1.8 years |
| Characterization of the pharmacokinetic profile of gimatecan | 1.8 years |
| Anti-tumor activity assessed by RECIST | 1.8 years |
Countries
Japan
Outcome results
None listed