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Sponsors and Collaborators: |
Rigshospitalet, Denmark Hoffmann-La Roche |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00452075 |
A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical Phase II Stage IIIB or IV non-small cell lung cancer (NSCLC) Primary end point: Disease control rate (= CR+PR and SD at 8 weeks /patients). Secondary end point: Safety (Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected TarcevaTM related AEs) .Correlation of EGFR expression rate (HER1) and FISH potentially predictive for response.
An open-label, non randomized, multicenter, clinical trial of TarcevaTM as single agent The sample size is 29 patients in 2 stages and based on Simon´s optimal 2 stage design. Stage 1 will accrue 10 patients, if less than 1 response is observed the study will stop; if more than 1 response is observed the accrual will continue up till 29 patients. A total of 29 patients would be entered and the treatment will be declared to have sufficient activity to deserve further attention if at least 5 patients obtain disease control.
Condition | Intervention | Phase |
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Non Small Cell Lung Cancer |
Drug: erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase II Study of Erlotinib and Predictive Markers as First-Line Treatment of Advanced Non-Small Cell Lung Cancer for Patients Unfit for Chemotherapy |
Estimated Enrollment: | 29 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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arm 1 medicine: Experimental
erlotinib daily
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Drug: erlotinib
150mg daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Helle Pappot, MD, DMSc | 004535458747 | pappot@rh.regionh.dk |
Contact: Gedske Daugaard, MD, DMsc | 004535453545 | gedske@rh.regionh.dk |
Denmark | |
Department of Oncology, Rigshospitalet | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Helle Pappot, MD, DMSc 0035458747 pappot@rh.regionh.dk | |
Principal Investigator: Helle Pappot, MD, DMSc | |
Department of Oncology, Odense University Hospital | Recruiting |
Odense, Denmark, 5000 | |
Contact: Olfred Hansen, MD | |
Principal Investigator: Olfred Hansen, MD | |
Department of Oncology, Århus University Hospital | Not yet recruiting |
Århus, Denmark, 8000 | |
Contact: Peter Meldgaard, MD | |
Principal Investigator: Peter Melsdgaard |
Principal Investigator: | Pappot Helle, MD, DMSC | Department of Oncology, Rigshospitalet, Denmark |
Responsible Party: | Rigshospitalet ( Helle Pappot, MD ) |
Study ID Numbers: | ML 20539 |
Study First Received: | March 23, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00452075 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency |
EGFR expression erlotinib |
Erlotinib Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Protein Kinase Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |