A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00487058

Purpose

This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: Gimatecan	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: 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 Twice Per Week to Japanese Patients With Advanced Solid Tumors.

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST)

Estimated Enrollment:	28
Study Start Date:	May 2007
Primary Completion Date:	June 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 progressed despite standard therapy or for whom no standard therapy exists
Life expectancy of at least 3 months
No dysfunction of bone marrow
No major impairment of renal and hepatic function

Exclusion criteria

Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug
Receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy
Receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days
Patients known to be HIV, or hepatitis B or C viruses 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 of drugs

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487058

Locations

Japan

Saitama prefecture, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLBQ707A1103
Study First Received:	June 14, 2007
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00487058
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 January 16, 2009