A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: Gimatecan	Phase I

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Gimatecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Estimated Maximum Tolerated Dose of gimatecan

Secondary Outcome Measures:

Safety assessed by adverse events
Characterization of the pharmacokinetic profile of gimatecan
Anti-tumor activity assessed by RECIST

Estimated Enrollment:	30
Study Start Date:	June 2006
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410358

Locations


Japan

	Chiba Prefecture, Japan

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLBQ707A1101
First Received:	December 11, 2006
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00410358
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:

Gimatecan

topoisomerase I inhibitor

advanced solid tumors

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00410358