A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Solid Tumors
Intervention: topotecan (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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.
Secondary outcome: This study has no secondary outcome measures.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, New York, New York 10021, United States
GSK Clinical Trials Call Center, Ottawa, Ontario K1H 1C4, Canada
GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19111, United States
GSK Clinical Trials Call Center, Nashville, Tennessee 37203-1632, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
Additional Information
Starting date: February 2002
Last updated: March 6, 2006
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