Lung Cancer, Small CellPhase 1NCT00259935
A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
A Phase 1 study testing topotecan in people with Lung Cancer, Small Cell, run by GlaxoSmithKline at 8 sites in 2 countries.
Trial summary
The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Small Cell
- What is being tested?
- topotecan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 4 Oct 2004to 5 Jul 2007
- 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
- Subjects with advanced solid tumors.
- At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
- Subjects must be free of post-treatment side effects.
Who cannot join
- Women who are pregnant or lactating
- Subjects with uncontrolled emesis, regardless of etiology, active infection.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
GSK Investigational Site
Lebanon, New Hampshire, 03756
GSK Investigational Site
Morgantown, West Virginia, 26506
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Philadelphia, Pennsylvania, 19111
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
The Bronx, New York, 10461
Netherlands2 sites
GSK Investigational Site
Amsterdam, 1066 CX
GSK Investigational Site
Utrecht, 3584 CX
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 (4C)
The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.
- Conditions
- Lung Cancer, Small Cell
- Being tested
- topotecan
- Keywords
- Any Solid Tumor
- 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
topotecan
| Study group | Role | What they receive |
|---|---|---|
| All treated subjects | Experimental | Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1. Receives: Drug: topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2.
Measured: Days 1, 8
Secondary outcomes (1)
Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1
Measured: Up to 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study start4 Oct 2004
- Primary completion5 Jul 2007
- Study completion5 Jul 2007
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
- 107 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
- NCT00259935
- Sponsor's protocol ID
- 104864/692
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2005
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 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 (4C)
- ClinicalTrials.gov ID
- NCT00259935
- Acronym / sponsor ID
- 104864/692
- Conditions
- Lung Cancer, Small Cell
- Keywords
- Any Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2004 (actual)
- Primary completion
- 5 Jul 2007 (actual)
- Study completion
- 5 Jul 2007 (actual)
- First posted
- 1 Dec 2005 (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 determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All treated subjects | Experimental | Drug: topotecanSubjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with advanced solid tumors.
- At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
- Subjects must be free of post-treatment side effects.
Key exclusion criteria (2 listed)
- Women who are pregnant or lactating
- Subjects with uncontrolled emesis, regardless of etiology, active infection.
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 |
|---|---|---|
| topotecantopotecan | Drug | All treated subjects |
Primary outcome
Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2.
Time frame: Days 1, 8
1 secondary outcome
Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1
Time frame: Up to 38 days
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 14 Nov 2017.
- Results for study 104864/692 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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
8 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, run by GlaxoSmithKline at 8 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 3 inclusion and 2 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 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Netherlands. 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?
Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2. (time frame: Days 1, 8). 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 14 Nov 2017.