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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259935
First Posted: December 1, 2005
Last Update Posted: November 14, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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 Intervention Phase
Lung Cancer, Small Cell Drug: topotecan Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 107
Actual Study Start Date: October 4, 2004
Study Completion Date: July 5, 2007
Primary Completion Date: July 5, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00259935


Locations
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
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00259935     History of Changes
Other Study ID Numbers: 104864/692
First Submitted: November 30, 2005
First Posted: December 1, 2005
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents