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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410358
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : October 16, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Gimatecan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.
Study Start Date : June 2006
Actual Primary Completion Date : February 2008

Arm Intervention/treatment
Experimental: LBQ707 Drug: Gimatecan
Other Name: LBQ707

Primary Outcome Measures :
  1. Estimated Maximum Tolerated Dose of gimatecan [ Time Frame: 1.8 years ]

Secondary Outcome Measures :
  1. Safety assessed by adverse events [ Time Frame: 1.8 years ]
  2. Characterization of the pharmacokinetic profile of gimatecan [ Time Frame: 1.8 years ]
  3. Anti-tumor activity assessed by RECIST [ Time Frame: 1.8 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410358

Novartis Investigative Site
Chiba Prefecture, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00410358     History of Changes
Other Study ID Numbers: CLBQ707A1101
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
topoisomerase I inhibitor
advanced solid tumors

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action