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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00410358
First received: December 11, 2006
Last updated: October 15, 2012
Last verified: October 2012

December 11, 2006
October 15, 2012
June 2006
February 2008   (final data collection date for primary outcome measure)
Estimated Maximum Tolerated Dose of gimatecan [ Time Frame: 1.8 years ] [ Designated as safety issue: Yes ]
Estimated Maximum Tolerated Dose of gimatecan
Complete list of historical versions of study NCT00410358 on ClinicalTrials.gov Archive Site
  • Safety assessed by adverse events [ Time Frame: 1.8 years ] [ Designated as safety issue: Yes ]
  • Characterization of the pharmacokinetic profile of gimatecan [ Time Frame: 1.8 years ] [ Designated as safety issue: No ]
  • Anti-tumor activity assessed by RECIST [ Time Frame: 1.8 years ] [ Designated as safety issue: No ]
  • Safety assessed by adverse events
  • Characterization of the pharmacokinetic profile of gimatecan
  • Anti-tumor activity assessed by RECIST
Not Provided
Not Provided
 
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: Gimatecan
Other Name: LBQ707
Experimental: LBQ707
Intervention: Drug: Gimatecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
Not Provided
February 2008   (final data collection date for primary outcome measure)

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

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00410358
CLBQ707A1101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP