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

April 17, 2013 updated by: Novartis Pharmaceuticals

A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • MD Anderson Cancer Center - Orlando
      • Copenhagen, Denmark, DK-2100
        • Novartis Investigative Site
      • Dijon Cedex, France, 21034
        • Novartis Investigative Site
      • Paris, France, 75005
        • Novartis Investigative Site
      • Saint-Herblain Cedex, France, 44805
        • Novartis Investigative Site
      • Toulouse, France, 31052
        • Novartis Investigative Site
      • Mainz, Germany, 55101
        • Novartis Investigative Site
      • Tubingen, Germany, 72076
        • Novartis Investigative Site
      • Enschede, Netherlands
        • Novartis Investigative Site
      • Oslo, Norway, 310
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daily times five schedule
Experimental: Continuous schedule, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of dose limiting toxicities in a 56-day treatment period
Time Frame: 56 days
56 days

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability assessed by adverse events, serious adverse events
Time Frame: 112 days
112 days
pharmacokinetics of gimatecan and its metabolites(s)
Time Frame: 91 days
91 days
response rate assessed by anti-tumor activity
Time Frame: 112 days
112 days
investigate tumor-specific mutations
Time Frame: 57 days
57 days
Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC
Time Frame: 56 days
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

April 19, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBQ707A2101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumors

Clinical Trials on gimatecan

3
Subscribe