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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259935
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Small Cell Drug: topotecan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 4, 2004
Actual Primary Completion Date : July 5, 2007
Actual Study Completion Date : July 5, 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259935

United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10461
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, West Virginia
GSK Investigational Site
Morgantown, West Virginia, United States, 26506
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline Identifier: NCT00259935     History of Changes
Other Study ID Numbers: 104864/692
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
Any Solid Tumor

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents