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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 is ongoing, but not recruiting participants.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00441610
  Purpose

CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.


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: 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:

Primary Outcome Measures:
  • Safety and tolerability assessed by Adverse Events
  • Anti-tumor activity assessed by RECIST criteria

Secondary Outcome Measures:
  • no secondary outcome measure

Estimated Enrollment: 10
Study Start Date: February 2007
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441610

Locations
Japan
Chiba, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CLBQ707A1101E1
Study First Received: February 28, 2007
Last Updated: July 24, 2008
ClinicalTrials.gov Identifier: NCT00441610  
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 14, 2009



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