A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Camptothecin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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