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

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410358
• Other study ID #: CLBQ707A1101
• Status: Completed
• Phase: Phase 1
• Start date: June 2006

Study information

• Verified date: October 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• Gimatecan

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chiba Prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Maximum Tolerated Dose of gimatecan		1.8 years
Secondary	Safety assessed by adverse events		1.8 years
Secondary	Characterization of the pharmacokinetic profile of gimatecan		1.8 years
Secondary	Anti-tumor activity assessed by RECIST		1.8 years

External Links

•   Results for CLBQ707A1101 can be found on the Novartis Clinical Trial Results Website