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
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Drug: Gimatecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Estimated Maximum Tolerated Dose of gimatecan [ Time Frame: 1.8 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: June 2006
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBQ707 Drug: Gimatecan
Other Name: LBQ707

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410358

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00410358     History of Changes
Other Study ID Numbers: CLBQ707A1101
Study First Received: December 11, 2006
Last Updated: October 15, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014