Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00683306 |
Expanded Access Status :
Approved for marketing
First Posted : May 23, 2008
Last Update Posted : September 13, 2018
|
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date | May 21, 2008 | |||
First Posted Date | May 23, 2008 | |||
Last Update Posted Date | September 13, 2018 | |||
Descriptive Information | ||||
Brief Title | Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment | |||
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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type | Expanded Access | |||
Expanded Access Type | Individual Patients | |||
Condition | Non Small Cell Lung Cancer (NSCLC) | |||
Intervention | Drug: ZD1839 (Iressa)
Gefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study.
Other Name: Iressa
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Expanded Access Status | Approved for marketing | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years to 130 Years (Adult, Older Adult) | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Argentina, Australia, Austria, Brazil, Bulgaria, Estonia, Hungary, India, Latvia, Malaysia, Mexico, Philippines, Romania, Russian Federation, Singapore, South Africa, Taiwan, Thailand, Turkey | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00683306 | |||
Other Study ID Numbers | D791AC00008 | |||
Current Responsible Party | AstraZeneca | |||
Original Responsible Party | Alison Armour (Medical Science Director), AstraZeneca Pharmaceuticals | |||
Current Study Sponsor | AstraZeneca | |||
Original Study Sponsor | Same as current | |||
Collaborators | Not Provided | |||
Investigators |
|
|||
PRS Account | AstraZeneca | |||
Verification Date | August 2018 |