Status:
COMPLETED
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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/exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00410358
Start Date
June 1 2006
Last Update
December 19 2020
Active Locations (1)
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1
Novartis Investigative Site
Chiba Prefecture, Japan