Status:

COMPLETED

Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Solid Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Advanced or metastatic cancer
  • 18 years and above
  • Exclusion criteria:
  • Previous treatment with 4 or more cycles of carboplatin;
  • Previous treatment with 2 or more courses of nitrosourea or mitomycin;
  • Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
  • Severe and/or uncontrolled medical conditions
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2010

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT00420485

    Start Date

    March 1 2006

    End Date

    November 1 2010

    Last Update

    April 19 2013

    Active Locations (12)

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    Page 1 of 3 (12 locations)

    1

    Novartis Investigative Site

    Vancouver, British Columbia, Canada

    2

    MD Anderson Cancer Center - Orlando

    Toronto, Ontario, Canada, M5G 2M9

    3

    Novartis Investigative Site

    Copenhagen, Denmark, DK-2100

    4

    Novartis Investigative Site

    Dijon, France, 21034