Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00049998
Other study ID # 104864-A/387
Secondary ID
Status Completed
Phase Phase 3
First received November 18, 2002
Last updated March 1, 2013
Start date October 2001

Study information

Verified date March 2013
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 760
Est. completion date
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
topotecan


Locations

Country Name City State
Australia GSK Investigational Site Adelaide South Australia
Australia GSK Investigational Site Bedford Park South Australia
Australia GSK Investigational Site Melbourne Victoria
Australia GSK Investigational Site Ringwood East Victoria
Austria GSK Investigational Site Innsbruck
Austria GSK Investigational Site St Poelten
Austria GSK Investigational Site Vienna
Belgium GSK Investigational Site Braasschaat
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Edegem
Belgium GSK Investigational Site Liege
Canada GSK Investigational Site Greenfield Park Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Oshawa Ontario
Canada GSK Investigational Site Sainte-Foy Quebec
Canada GSK Investigational Site Sydney Nova Scotia
Canada GSK Investigational Site Thunder Bay Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
China GSK Investigational Site Beijing
China GSK Investigational Site Shanghai
China GSK Investigational Site Shanghai
China GSK Investigational Site Tianjin
China GSK Investigational Site Wangfujing, Beijing
China GSK Investigational Site Xian Shaanxi
Czech Republic GSK Investigational Site Ceske Budejovice
Czech Republic GSK Investigational Site Kladno
Czech Republic GSK Investigational Site Praha 4
Denmark GSK Investigational Site Herlev
Denmark GSK Investigational Site Odense C
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Turku
France GSK Investigational Site Caen Cedex 5
France GSK Investigational Site Dijon Cedex
France GSK Investigational Site Strasbourg Cedex
France GSK Investigational Site Toulon Naval
France GSK Investigational Site Vesoul Cedex
Germany GSK Investigational Site Bad Berka Thueringen
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Gauting Bayern
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Regensburg Bayern
Germany GSK Investigational Site Treuenbrietzen Brandenburg
Greece GSK Investigational Site Athens
Greece GSK Investigational Site Heraklion, Crete
Greece GSK Investigational Site Papagos, Athens
Greece GSK Investigational Site Rio, Patras
Greece GSK Investigational Site Thessaloniki
Hungary GSK Investigational Site Budapest
Hungary GSK Investigational Site Csorna
Hungary GSK Investigational Site Miskolc
Israel GSK Investigational Site Ashkelon
Israel GSK Investigational Site Beer-Sheva
Israel GSK Investigational Site Ramat Gan
Israel GSK Investigational Site Tel Aviv
Italy GSK Investigational Site Perugia Umbria
Italy GSK Investigational Site Roma Lazio
Italy GSK Investigational Site Sassari Sardegna
Italy GSK Investigational Site Torino Piemonte
Italy GSK Investigational Site Verona Veneto
Latvia GSK Investigational Site Riga
Latvia GSK Investigational Site Riga
Lithuania GSK Investigational Site Kaunas
Lithuania GSK Investigational Site Vilnius
Netherlands GSK Investigational Site 's-HERTOGENBOSCH
Netherlands GSK Investigational Site Delft
Netherlands GSK Investigational Site Groningen
Netherlands GSK Investigational Site Heerlen
Netherlands GSK Investigational Site Leeuwarden
New Zealand GSK Investigational Site Newtown, Wellington
Philippines GSK Investigational Site Quezon City
Poland GSK Investigational Site Poznan
Poland GSK Investigational Site Warszawa
Portugal GSK Investigational Site Lisboa
Portugal GSK Investigational Site Porto
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site N. Novgorod
Russian Federation GSK Investigational Site Samara
Russian Federation GSK Investigational Site St. Petersburg
Singapore GSK Investigational Site Singapore
South Africa GSK Investigational Site Cape Town Western Province
South Africa GSK Investigational Site Port Elizabeth
South Africa GSK Investigational Site Pretoria Gauteng
Spain GSK Investigational Site Barakaldo (Vizcaya)
Spain GSK Investigational Site Jaen
Spain GSK Investigational Site La Laguna (Santa Cruz de Tenerife)
Spain GSK Investigational Site Lerida
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Malaga
Spain GSK Investigational Site Palma de Mallorca
Spain GSK Investigational Site Pontevedra
Spain GSK Investigational Site Valencia
Switzerland GSK Investigational Site Zurich
Taiwan GSK Investigational Site Taipei
Taiwan GSK Investigational Site Tau-Yuan County
Thailand GSK Investigational Site Bangkok
Thailand GSK Investigational Site Chiang Mai
Turkey GSK Investigational Site Istanbul
Turkey GSK Investigational Site Izmir
Ukraine GSK Investigational Site Kharkov
Ukraine GSK Investigational Site Lugansk
Ukraine GSK Investigational Site Lvov
United Kingdom GSK Investigational Site Dundee Forfarshire
United Kingdom GSK Investigational Site Glasgow Lanarkshire
United Kingdom GSK Investigational Site Guildford Surrey
United Kingdom GSK Investigational Site Leicester Leicestershire
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Nottingham Nottinghamshire

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Canada,  China,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Latvia,  Lithuania,  Netherlands,  New Zealand,  Philippines,  Poland,  Portugal,  Russian Federation,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary One-year survival rate
Secondary 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.
See also
  Status Clinical Trial Phase
Terminated NCT02495233 - A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI) Phase 1/Phase 2
Withdrawn NCT02672358 - Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC Phase 2
Recruiting NCT05815472 - Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT) N/A
Not yet recruiting NCT05900219 - Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study Phase 2
Not yet recruiting NCT04560244 - A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment Phase 2
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Completed NCT01924416 - Lung Cancer Information Study (LCIS-R01) N/A
Completed NCT01136083 - Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients N/A
Completed NCT00831454 - Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection N/A
Completed NCT00363766 - Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Completed NCT00913705 - Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer Phase 3
Completed NCT01383135 - Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2 Early Phase 1
Completed NCT01124864 - A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy. Phase 2
Terminated NCT05061537 - Study of PF-07263689 in Participants With Selected Advanced Solid Tumors Phase 1
Completed NCT03320044 - Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
Recruiting NCT04895930 - Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC Phase 2
Recruiting NCT03267654 - Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance Phase 2
Recruiting NCT04401059 - Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Prospective Study Phase 4
Not yet recruiting NCT02930954 - Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance Phase 2
Not yet recruiting NCT02938546 - 18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study Phase 3