Solid Tumors Clinical Trial
Official title:
A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
Status | Completed |
Enrollment | 120 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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/exclusion criteria may apply |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | MD Anderson Cancer Center - Orlando | Toronto | Ontario |
Canada | Novartis Investigative Site | Vancouver | British Columbia |
Denmark | Novartis Investigative Site | Copenhagen | |
France | Novartis Investigative Site | Dijon Cedex | |
France | Novartis Investigative Site | Paris | |
France | Novartis Investigative Site | Saint-Herblain Cedex | |
France | Novartis Investigative Site | Toulouse | |
Germany | Novartis Investigative Site | Mainz | |
Germany | Novartis Investigative Site | Tubingen | |
Netherlands | Novartis Investigative Site | Enschede | |
Norway | Novartis Investigative Site | Oslo | |
Spain | Novartis Investigative Site | Madrid |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Canada, Denmark, France, Germany, Netherlands, Norway, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of dose limiting toxicities in a 56-day treatment period | 56 days | Yes | |
Secondary | safety and tolerability assessed by adverse events, serious adverse events | 112 days | Yes | |
Secondary | pharmacokinetics of gimatecan and its metabolites(s) | 91 days | Yes | |
Secondary | response rate assessed by anti-tumor activity | 112 days | No | |
Secondary | investigate tumor-specific mutations | 57 days | No | |
Secondary | Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC | 56 days | No |
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