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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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00441610
Collaborator
(none)
4
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
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
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gimatecan

Drug: Gimatecan
Other Names:
  • LBQ707

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability assessed by Adverse Events [2.8 years]

    2. Anti-tumor activity assessed by RECIST criteria [2.8 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Chiba Japan

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00441610
    Other Study ID Numbers:
    • CLBQ707A1101E1
    First Posted:
    Mar 1, 2007
    Last Update Posted:
    Dec 19, 2020
    Last Verified:
    Apr 1, 2012
    Keywords provided by Novartis Pharmaceuticals
    Gimatecan
    topoisomerase I inhibitor
    advanced solid tumors
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Dec 19, 2020