A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors

GlaxoSmithKline107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Lung Cancer, Small Cell

Interventions

topotecanDRUG

topotecan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

GSK Investigational Site

Lebanon, New Hampshire, United States

GSK Investigational Site

The Bronx, New York, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: Days 1, 8

Secondary Outcomes

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

Time frame: Up to 38 days

Data from ClinicalTrials.gov

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