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

Novartis

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: Gimatecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00410358

CLBQ707A1101

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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