Solid Tumors
Conditions
Keywords
Maximum Tolerated Dose, Solid Tumors, Dose Limiting Toxicity, Topoisomerase-1 Inhibitor
Brief summary
This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
Interventions
DRUGgimatecan
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
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
* Advanced or metastatic cancer * 18 years and above
Exclusion criteria
* Previous treatment with 4 or more cycles of carboplatin; * Previous treatment with 2 or more courses of nitrosourea or mitomycin; * Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve; * Severe and/or uncontrolled medical conditions Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of dose limiting toxicities in a 56-day treatment period | 56 days |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability assessed by adverse events, serious adverse events | 112 days |
| pharmacokinetics of gimatecan and its metabolites(s) | 91 days |
| response rate assessed by anti-tumor activity | 112 days |
| investigate tumor-specific mutations | 57 days |
| Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC | 56 days |
Countries
Canada, Denmark, France, Germany, Netherlands, Norway, Spain
Outcome results
None listed