A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors

November 10, 2017 updated by: GlaxoSmithKline

A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors (4C)

The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

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

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • GSK Investigational Site
      • Utrecht, Netherlands, 3584 CX
        • GSK Investigational Site
  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • GSK Investigational 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with advanced solid tumors.
  • At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
  • Subjects must be free of post-treatment side effects.

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Subjects with uncontrolled emesis, regardless of etiology, active infection.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All treated subjects
Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1.
Drug: topotecan
topotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2.
Time Frame: Days 1, 8
Days 1, 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1
Time Frame: Up to 38 days
Up to 38 days

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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 (Actual)

October 4, 2004

Primary Completion (Actual)

July 5, 2007

Study Completion (Actual)

July 5, 2007

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104864/692

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.

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