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Efficacy and Safety of Patupilone in Patients With Advanced Solid Tumors in Japan

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00412789
Collaborator
(none)
15
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IA, Open-label, Dose Escalation Study of Patupilone Administered Intravenously Every 3 Weeks in Adult Patients With Advanced Solid Tumors
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: EPO906

Drug: Patupilone
Other Names:
  • EPO906

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose-limiting Toxicity [18 months]

    Secondary Outcome Measures

    1. Safety and tolerability of patupilone assessed by CTCAE [18 months]

    2. Pharmacokinetic profile of patupilone [18 months]

    3. Anti-tumor activity of patupilone according to the RECIST guidelines [18 months]

    Eligibility Criteria

    Criteria

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

    • Patients with a histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to or unsuitable for standard therapy, or for whom no standard therapy exists

    • Patients with WHO Performance Status of 0-1 ( Karnofsky Performance Status of 80-100)

    • At least one measurable lesion

    Exclusion criteria:

    • Patients with any peripheral neuropathy

    • Patients with unresolved diarrhea

    • Patients with severe and/or uncontrolled medical conditions or infections that require systemic therapy

    Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00412789
    Other Study ID Numbers:
    • CEPO906A1103
    First Posted:
    Dec 18, 2006
    Last Update Posted:
    May 31, 2010
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    Advanced solid tumor
    Patupilone
    Additional relevant MeSH terms:
    Neoplasms
    Epothilone B

    Study Results

    No Results Posted as of May 31, 2010