Last updated: 11/03/2018 07:44:29
A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors
GSK study ID
104864-A/565
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: Four weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: topotecan
Enrollment:
1
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Small Cell, Solid Tumor Cancer
Product
topotecan
Collaborators
Not applicable
Study date(s)
September 2001 to May 2003
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Written informed consent
- Patients with confirmed advanced solid tumors.
- Women who are pregnant or lactating.
- Patients of child bearing potential refusing to practice adequate contraception.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2003-29-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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