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:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00259935
First received: November 30, 2005
Last updated: March 17, 2011
Last verified: March 2011
  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
Tumor
Lung Cancer, Small Cell
Drug: topotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

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.

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

Estimated Enrollment: 106
Study Start Date: October 2004
Intervention Details:
    Drug: topotecan
    Other Name: topotecan
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00259935     History of Changes
Other Study ID Numbers: 104864/692
Study First Received: November 30, 2005
Last Updated: March 17, 2011
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Any Solid Tumor

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

ClinicalTrials.gov processed this record on October 16, 2014