A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.|
- Estimated Maximum Tolerated Dose of gimatecan [ Time Frame: 1.8 years ] [ Designated as safety issue: Yes ]
- Safety assessed by adverse events [ Time Frame: 1.8 years ] [ Designated as safety issue: Yes ]
- Characterization of the pharmacokinetic profile of gimatecan [ Time Frame: 1.8 years ] [ Designated as safety issue: No ]
- Anti-tumor activity assessed by RECIST [ Time Frame: 1.8 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|