A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00046111
First received: September 19, 2002
Last updated: May 12, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Lung Cancer, Small Cell
Solid Tumor Cancer
Drug: topotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics 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:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2001
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: topotecan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00046111     History of Changes
Other Study ID Numbers: 104864-A/565
Study First Received: September 19, 2002
Last Updated: May 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
oral
Bioequivalence
Hycamtin
Topotecan

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

ClinicalTrials.gov processed this record on October 23, 2014