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An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00441610
First Posted: March 1, 2007
Last Update Posted: May 1, 2012
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.

Condition Intervention Phase
Advanced Solid Tumors Drug: Gimatecan Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Trial to 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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Safety and tolerability assessed by Adverse Events [ Time Frame: 2.8 years ]
  • Anti-tumor activity assessed by RECIST criteria [ Time Frame: 2.8 years ]

Enrollment: 4
Study Start Date: January 2007
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gimatecan Drug: Gimatecan
Other Name: LBQ707

  Eligibility

Information from the National Library of Medicine

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

Inclusion criteria:

  • Patients completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable disease, or a partial or complete response as defined by the core protocol. If patients only have non-measurable lesions, he/she must not be exhibiting progressive disease

Exclusion criteria:

  • Documented progressive disease as defined by the core protocol
  • Patients with performance status of 3 or 4 on the ECOG scale

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00441610


Locations
Japan
Novartis Investigative Site
Chiba, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00441610     History of Changes
Other Study ID Numbers: CLBQ707A1101E1
First Submitted: February 28, 2007
First Posted: March 1, 2007
Last Update Posted: May 1, 2012
Last Verified: April 2012

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

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