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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00046111
Other study ID # 104864-A/565
Secondary ID
Status Completed
Phase Phase 1
First received September 19, 2002
Last updated May 24, 2017
Start date September 2001
Est. completion date April 2004

Study information

Verified date May 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
topotecan
A topoisomerase I inhibitor used for ovarian and lung cancer treatment

Locations

Country Name City State
Canada GSK Investigational Site Ottawa Ontario
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site New York New York
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,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Four weeks
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