Non Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
| NCT number | NCT00683306 |
| Other study ID # | D791AC00008 |
| Secondary ID | |
| Status | Approved for marketing |
| Phase | |
| First received | |
| Last updated |
| Verified date | August 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.
| Status | Approved for marketing |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility |
Inclusion Criteria: - Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment. - No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician. Exclusion Criteria: - Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded). - In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease). - Withdrawal, at any time, from the preceding gefitinib study. - Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | La Plata | |
| Australia | Research Site | Concord | |
| Austria | Research Site | Graz | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Wien | |
| Brazil | Research Site | Fortaleza | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Rio de Janeiro | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | Sorocaba | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Varna | |
| Bulgaria | Research Site | Veliko Tarnovo | |
| Estonia | Research Site | Tallinn | |
| Estonia | Research Site | Tartu | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Deszk | |
| Hungary | Research Site | Mosdós | |
| Hungary | Research Site | Pécs | |
| Hungary | Research Site | Zalaegerszeg | |
| India | Research Site | Hyderabad | |
| India | Research Site | Karnataka | |
| India | Research Site | Kolkata | |
| India | Research Site | Mumbai | |
| India | Research Site | New Delhi | |
| India | Research Site | Pune | |
| India | Research Site | Vellore | |
| Latvia | Research Site | Daugavpils | |
| Latvia | Research Site | Riga | |
| Malaysia | Research Site | Kuala Lumpur | |
| Malaysia | Research Site | Nilai | |
| Malaysia | Research Site | Penang | |
| Malaysia | Research Site | Penang | |
| Malaysia | Research Site | Penang | |
| Mexico | Research Site | Durango | |
| Mexico | Research Site | Mexico Distrito Federal | |
| Mexico | Research Site | Monterrey | |
| Mexico | Research Site | Torreon | |
| Philippines | Research Site | Manila | |
| Philippines | Research Site | Pasig | |
| Philippines | Research Site | Quezon City | |
| Philippines | Research Site | Quezon City | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Iasi | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Singapore | Research Site | Singapore | |
| South Africa | Research Site | Johannesburg | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Tao-Yuan | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Chiang Mai | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Argentina, Australia, Austria, Brazil, Bulgaria, Estonia, Hungary, India, Latvia, Malaysia, Mexico, Philippines, Romania, Russian Federation, Singapore, South Africa, Taiwan, Thailand, Turkey,
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01204099 -
Study of PX-866 and Docetaxel in Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04083599 -
GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00148798 -
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
|
Phase 3 | |
| Recruiting |
NCT06026410 -
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02988817 -
Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01005797 -
Study of Panobinostat in Combination With Sorafenib in Kidney, Soft Tissue or Lung Cancers
|
Phase 1 | |
| Recruiting |
NCT00637910 -
Tarceva Italian Lung Optimization tRial
|
Phase 3 | |
| Active, not recruiting |
NCT03447678 -
Pembrolizumab in First Line Treatment of Advanced NSCLC Patients With PD-L1 Low Tumors.
|
Phase 2 | |
| Completed |
NCT02456246 -
Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT
|
N/A | |
| Terminated |
NCT01741155 -
Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)
|
Phase 2 | |
| Completed |
NCT02014324 -
Single Scope Staging of Lung Cancer With Endosonography
|
N/A | |
| Completed |
NCT01594398 -
Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT01323062 -
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT04772989 -
A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT01702844 -
Single Arm on the Tolerability of Weekly Nab-paclitaxel
|
Phase 2 | |
| Completed |
NCT00492206 -
Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
|
Phase 2 | |
| Completed |
NCT00820417 -
Pharmocokinetic/Pharmacodynamic (PK/PD) Study of the Combination Cetuximab/Gefitinib
|
Phase 1 | |
| Completed |
NCT02639026 -
Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers
|
Phase 1 | |
| Completed |
NCT01282437 -
Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC
|
Phase 3 | |
| Active, not recruiting |
NCT04721015 -
Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors
|
Phase 1 |