An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

Phase 1

Completed

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

• Registration Number: NCT00441610
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-01
• Primary Completion: 2009-09
• Status Verified: 2012-04
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gimatecan	Gimatecan	-

Primary Outcome Measures

Name	Time	Method
Anti-tumor activity assessed by RECIST criteria	2.8 years
Safety and tolerability assessed by Adverse Events	2.8 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Chiba, Japan