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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: Gimatecan

• Registration Number: NCT00410358
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Study First Posted: 2006-12-12
• Primary Completion: 2008-02
• Status Verified: 2012-10
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LBQ707	Gimatecan	-

Primary Outcome Measures

Name	Time	Method
Estimated Maximum Tolerated Dose of gimatecan	1.8 years

Secondary Outcome Measures

Name	Time	Method
Anti-tumor activity assessed by RECIST	1.8 years
Safety assessed by adverse events	1.8 years
Characterization of the pharmacokinetic profile of gimatecan	1.8 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Chiba Prefecture, Japan