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A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients with Stage IIIB/IV Non-small Cell Lung Cancer who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT00294736

Astellas Study ID

The unique identification code given by the study sponsor.

OSI-774-107

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2005-003883-46

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Condition

Non Small Cell Lung Cancer

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 Years - N/A N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Nov 2005 - Sep 2007

Masking

None (Open Label)

Enrollment number

57

A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva® (erlotinib) in Patients with Stage IIIB/IV Non-small Cell Lung Cancer Who Continue To Smoke After Failure of One or Two Prior Chemotherapy Regimens

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Royal Marsden Hospital

Sutton, United Kingdom, SM2 5PT

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN

University of Edinburgh,Division of Oncology,

Edinburgh, United Kingdom, EH4 2XU

Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

Sir Bobby Robson Cancer Trials Research Centre

Newcastle upon Tyne, United Kingdom, NE7 7DH

Department of Oncology

Sheffield, United Kingdom, S10 2SJ

Comprehensive Blood and Cancer Center

Bakersfield, United States, 93309

Wake Forest University Comprehensive Cancer Center

Winston-Salem, United States, 27157

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