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A Bioequivalence Study of Two Oral Formulations of Topotecan 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.
ClinicalTrials.gov Identifier: NCT00046111
Recruitment Status : Completed
First Posted : September 23, 2002
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 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
Study Start Date : September 2001
Primary Completion Date : April 2004
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Primary Group
40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks.
Drug: topotecan
A topoisomerase I inhibitor used for ovarian and lung cancer treatment


Outcome Measures

Primary Outcome Measures :
  1. To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors. [ Time Frame: Four weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Written informed consent
  • Patients with confirmed advanced solid tumors.
  • No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung cancer).
  • At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
  • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion criteria:

  • Women who are pregnant or lactating.
  • Patients of child bearing potential refusing to practice adequate contraception.
  • Patients with uncontrolled vomiting.
  • Active infection.
  • Patients with clinical evidence of any gastrointestinal (GI) conditions which would alter GI absorption or GI motility.
  • Patients requiring treatment with cyclosporin A.
  • Severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
  • Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment.
  • Use of investigational drug within 30 days prior to the first dose of study medication.
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): NCT00046111


Locations
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
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
Canada, Ontario
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 1C4
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00046111     History of Changes
Other Study ID Numbers: 104864-A/565
First Posted: September 23, 2002    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
oral
Bioequivalence
Hycamtin
Topotecan

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