Lung Cancer, Small CellPhase 1NCT00046111
A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors
A Phase 1 study testing topotecan in people with Lung Cancer, Small Cell and Solid Tumor Cancer, run by GlaxoSmithKline at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Small Cell, Solid Tumor Cancer
- What is being tested?
- topotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2001to Apr 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Philadelphia, Pennsylvania, 19111
GSK Investigational Site
San Antonio, Texas, 78229
About this study
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
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.
- Conditions
- Lung Cancer, Small Cell, Solid Tumor Cancer
- Being tested
- topotecan
- Keywords
- oral, Bioequivalence, Hycamtin, Topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecanDrug
A topoisomerase I inhibitor used for ovarian and lung cancer treatment
| Study group | Role | What they receive |
|---|---|---|
| Primary Group | Experimental | 40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks. Receives: Drug: topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2002 (estimated)
- Study startSep 2001
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Small CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046111
- Sponsor's protocol ID
- 104864-A/565
- Status last verified
- May 2017
- First submitted
- 19 Sep 2002
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00046111
- Acronym / sponsor ID
- 104864-A/565
- Conditions
- Lung Cancer, Small Cell, Solid Tumor Cancer
- Keywords
- oral, Bioequivalence, Hycamtin, Topotecan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 23 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Group | Experimental | Drug: topotecan40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topotecanA topoisomerase I inhibitor used for ovarian and lung cancer treatment | Drug | Primary Group |
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.
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topotecan in people with Lung Cancer, Small Cell and Solid Tumor Cancer, run by GlaxoSmithKline at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.