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Completed

NCT Number: NCT00046111

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

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.

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Key information

Conditions

Lung Cancer, Small Cell Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Solid Tumor Cancer Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topotecan

Drug

A topoisomerase I inhibitor used for ovarian and lung cancer treatment

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Sep 23, 2002
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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