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NCT00259935 Clinical Trial

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

Lung Cancer, Small Cell Clinical Trial

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 (4C)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00259935
Other study ID # 104864/692
Secondary ID
Status Completed
Phase Phase 1
First received November 30, 2005
Last updated November 10, 2017
Start date October 4, 2004
Est. completion date July 5, 2007

Study information
Verified date November 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 107
Est. completion date July 5, 2007
Est. primary completion date July 5, 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• topotecan
topotecan

Locations
Country Name City State
Netherlands GSK Investigational Site Amsterdam
Netherlands GSK Investigational Site Utrecht
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Lebanon New Hampshire
United States GSK Investigational Site Morgantown West Virginia
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Days 1, 8
Secondary 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 Up to 38 days
See also
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Completed NCT00997061 - SCOT Registry: Small Cell Lung Cancer Treatment and Outcome N/A
Completed NCT00276276 - Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer Phase 3
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Completed NCT00698516 - Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer Phase 2
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Terminated NCT01313663 - A Study to Evaluate Pazopanib in Comparison to Pemetrexed in Maintenance Setting in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) Population Phase 2
Active, not recruiting NCT04660929 - CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors Phase 1
Completed NCT00043862 - The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC) Phase 2
Completed NCT00320359 - Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer Phase 3
Recruiting NCT06228326 - A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs Phase 1
Completed NCT04314895 - Trial of NanoPac Intratumoral Injection in Lung Cancer Phase 2

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