Non-Small-Cell Lung CancerPhase 3NCT00049998
Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer
A Phase 3 study testing topotecan in people with Non-Small-Cell Lung Cancer, run by GlaxoSmithKline at 114 sites in 31 countries.
Trial summary
The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- topotecan
- How many people
- 760 participants
- Where
- 114 sitesin 31 countries
- Study dates
- Oct 2001to Apr 2004
- Phase
- Phase 3
- 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 advanced non-small cell lung cancer (NSCLC).
- Patients who have received one previous chemotherapy for NSCLC.
- Full recovery from previous chemotherapy.
- Presence of either measurable or non-measurable disease by radiologic study or physical examination.
- At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
- At least 24 hours since prior radiotherapy providing that marked bone marrow suppression is NOT expected. Patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting).
- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
Who cannot join
- Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
- Active infection.
- Severe medical problems other than the diagnosis of NSCLC, 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 the treatment of NSCLC.
- Use of investigational drug within 30 days prior to the first dose of study medication.
- Women who are pregnant or lactating.
- Patients of child-bearing potential refusing to practice adequate birth control methods.
- Patients with conditions which might alter absorption of an oral drug.
Trial locations and contacts
114 sites in 31 countries.
114 sites in 31 countries
Spain11 sites
GSK Investigational Site
Barakaldo (Vizcaya), 48903
GSK Investigational Site
Jaén, 23007
GSK Investigational Site
La Laguna (Santa Cruz de Tenerife), 38320
GSK Investigational Site
Lleida, 25198
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28047
GSK Investigational Site
Málaga, 29020
GSK Investigational Site
Palma de Mallorca, 07014
GSK Investigational Site
Pontevedra, 36002
GSK Investigational Site
Valencia, 46009
Canada8 sites
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H1
GSK Investigational Site
Montreal, Quebec, H3A 1A1
GSK Investigational Site
Oshawa, Ontario, L1G 2B9
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5
GSK Investigational Site
Sydney, Nova Scotia, B1P 1P3
GSK Investigational Site
Thunder Bay, Ontario, P7B 6V4
GSK Investigational Site
Toronto, Ontario, M5G 2M9
GSK Investigational Site
Toronto, Ontario, M6S 1B5
Germany8 sites
GSK Investigational Site
Bad Berka, Thuringia, 99437
GSK Investigational Site
Berlin, State of Berlin, 14109
GSK Investigational Site
Gauting, Bavaria, 82131
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 21075
GSK Investigational Site
Leipzig, Saxony, 04207
GSK Investigational Site
Munich, Bavaria, 80336
GSK Investigational Site
Regensburg, Bavaria, 93049
GSK Investigational Site
Treuenbrietzen, Brandenburg, 14929
China6 sites
GSK Investigational Site
Beijing, 100036
GSK Investigational Site
Shanghai, 200433
GSK Investigational Site
Shanghai
GSK Investigational Site
Tianjin
GSK Investigational Site
Wangfujing, Beijing, 100730
GSK Investigational Site
Xi'an, Shaanxi, 710061
Russia6 sites
GSK Investigational Site
Moscow, 115 478
GSK Investigational Site
Moscow, 117 837
GSK Investigational Site
Moscow, 129 128
GSK Investigational Site
Nizhny Novgorod, 603 000
GSK Investigational Site
Saint Petersburg, 198255
GSK Investigational Site
Samara, 443066
United Kingdom6 sites
GSK Investigational Site
Dundee, Forfarshire, DD1 9SY
GSK Investigational Site
Glasgow, Lanarkshire, G4 0SF
GSK Investigational Site
Guildford, Surrey, GU2 7XX
GSK Investigational Site
Leicester, Leicestershire, LE1 5WW
GSK Investigational Site
London, London, SE1 9RT
GSK Investigational Site
Nottingham, Nottinghamshire
France5 sites
GSK Investigational Site
Caen, 14076
GSK Investigational Site
Dijon, 21079
GSK Investigational Site
Strasbourg, 67098
GSK Investigational Site
Toulon Naval, 83800
GSK Investigational Site
Vesoul, 70014
Greece5 sites
GSK Investigational Site
Athens, 11526
GSK Investigational Site
Heraklion, Crete, 71110
GSK Investigational Site
Papagos, Athens, 15669
GSK Investigational Site
Rio, Patras, 265 00
GSK Investigational Site
Thessaloniki, 54007
Italy5 sites
GSK Investigational Site
Perugia, Umbria, 06122
GSK Investigational Site
Rome, Lazio, 00149
GSK Investigational Site
Sassari, Sardinia, 07100
GSK Investigational Site
Turin, Piedmont, 10126
GSK Investigational Site
Verona, Veneto, 37135
Netherlands5 sites
GSK Investigational Site
's-Hertogenbosch, 5211 NL
GSK Investigational Site
Delft, 2625 AD
GSK Investigational Site
Groningen, 9721 SW
GSK Investigational Site
Heerlen, 6419 PC
GSK Investigational Site
Leeuwarden, 8934 AD
Australia4 sites
GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Bedford Park, South Australia, 5042
GSK Investigational Site
Melbourne, Victoria, 3004
GSK Investigational Site
Ringwood East, Victoria, 3128
Belgium4 sites
GSK Investigational Site
Braasschaat, 2930
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Liège, 4000
Israel4 sites
GSK Investigational Site
Ashkelon, 78306
GSK Investigational Site
Beersheba, 84101
GSK Investigational Site
Ramat Gan, 52621
GSK Investigational Site
Tel Aviv, 64239
Austria3 sites
GSK Investigational Site
Innsbruck, A-6020
GSK Investigational Site
Sankt Pölten, A-3100
GSK Investigational Site
Vienna, A-1220
Czechia3 sites
GSK Investigational Site
České Budějovice, 370 87
GSK Investigational Site
Kladno, 140 59
GSK Investigational Site
Prague, 14059
Hungary3 sites
GSK Investigational Site
Budapest, 1529
GSK Investigational Site
Csorna, 9300
GSK Investigational Site
Miskolc, 3529
South Africa3 sites
GSK Investigational Site
Cape Town, Western Province
GSK Investigational Site
Port Elizabeth, 6001
GSK Investigational Site
Pretoria, Gauteng
Ukraine3 sites
GSK Investigational Site
Kharkiv
GSK Investigational Site
Luhansk
GSK Investigational Site
Lviv, 79031
Denmark2 sites
GSK Investigational Site
Herlev
GSK Investigational Site
Odense C, DK-5000
Finland2 sites
GSK Investigational Site
Helsinki, 00029
GSK Investigational Site
Turku, 20520
Latvia2 sites
GSK Investigational Site
Riga, LV 1002
GSK Investigational Site
Riga, LV 1079
Lithuania2 sites
GSK Investigational Site
Kaunas, LT-50009
GSK Investigational Site
Vilnius, LT-08660
Poland2 sites
GSK Investigational Site
Poznan, 60-569
GSK Investigational Site
Warsaw, 02-781
Portugal2 sites
GSK Investigational Site
Lisbon, 1769-166
GSK Investigational Site
Porto, 4200-319
Taiwan2 sites
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Tau-Yuan County, 333
Thailand2 sites
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Chiang Mai, 50200
Turkey (Türkiye)2 sites
GSK Investigational Site
Istanbul, 34280
GSK Investigational Site
Izmir, 3510
About this study
Official title: An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- topotecan
- Keywords
- Nonsmall Cell Lung cancer, advanced, Second-line, topotecan, Hycamtin, oral, docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year survival rate
Secondary outcomes (1)
overall survival, time to progression, response rate, response duration, time to response, improvement in quality of life and patient well-being, and qualitative and quantitative toxicities.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2002 (estimated)
- Study startOct 2001
- Primary completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 760 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049998
- Sponsor's protocol ID
- 104864-A/387
- Status last verified
- Mar 2013
- First submitted
- 18 Nov 2002
- Last updated
- 4 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00049998
- Acronym / sponsor ID
- 104864-A/387
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- Nonsmall Cell Lung cancer, advanced, Second-line, topotecan, Hycamtin, oral, docetaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 760 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Apr 2004 (actual)
- First posted
- 20 Nov 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 collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Patients with advanced non-small cell lung cancer (NSCLC).
- Patients who have received one previous chemotherapy for NSCLC.
- Full recovery from previous chemotherapy.
- Presence of either measurable or non-measurable disease by radiologic study or physical examination.
Key exclusion criteria (8 listed)
- Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
- Active infection.
- Severe medical problems other than the diagnosis of NSCLC, 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 the treatment of NSCLC.
- Use of investigational drug within 30 days prior to the first dose of study medication.
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 |
|---|---|---|
| topotecan | Drug | – |
Primary outcome
One-year survival rate
1 secondary outcome
overall survival, time to progression, response rate, response duration, time to response, improvement in quality of life and patient well-being, and qualitative and quantitative toxicities.
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 4 Mar 2013.
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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, MD study director
GlaxoSmithKline
114 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topotecan in people with Non-Small-Cell Lung Cancer, run by GlaxoSmithKline at 114 sites in 31 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 8 inclusion and 8 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 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 114 sites in Spain, Canada, Germany, China, Russia and 26 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
One-year survival rate. 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 4 Mar 2013.