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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumor, Lung Cancer, Small Cell

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Netherlands: Medicines Evaluation Board (MEB)

Study ID:

104864/692

NCT ID:

NCT00259935

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Tumor
  • Lung Cancer, Small Cell
  • Any Solid Tumor
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteHooksett, New Hampshire  03106
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteMorgantown, West Virginia  26506