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

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

Sponsors

Lead Sponsor: GlaxoSmithKline

Source GlaxoSmithKline
Brief 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.

Overall Status Completed
Start Date September 2001
Completion Date April 2004
Primary Completion Date April 2004
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 1
Condition
Intervention

Intervention Type: Drug

Intervention Name: topotecan

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

Arm Group Label: Primary Group

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Location
Facility:
GSK Investigational Site | New York, New York, 10021, United States
GSK Investigational Site | Philadelphia, Pennsylvania, 19111, United States
GSK Investigational Site | Nashville, Tennessee, 37203, United States
GSK Investigational Site | San Antonio, Texas, 78229, United States
GSK Investigational Site | Ottawa, Ontario, K1H 1C4, Canada
Location Countries

Canada

United States

Verification Date

May 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Primary Group

Type: Experimental

Description: 40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov