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 twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.
Interventions
DRUGGimatecan
Sponsors
Novartis
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 progressed despite standard therapy or for whom no standard therapy exists * Life expectancy of at least 3 months * No dysfunction of bone marrow * No major impairment of renal and hepatic function
Exclusion criteria
* Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug * Receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy * Receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days * Patients known to be HIV, or hepatitis B or C viruses 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 of drugs Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST) | — |
Countries
Japan
Outcome results
None listed