A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01372384
First received: June 10, 2011
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: erlotinib [Tarceva] |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced, Metastatic or Recurrent Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival (tumour assessments according to RECIST criteria) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response rate (Investigator assessed) [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: erlotinib [Tarceva]
150 mg orally daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR)
- At least one measurable lesion according to RECIST criteria
- European Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematological, liver and renal function
- Patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible
Exclusion Criteria:
- Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized >/= 6 months before entering the study)
- History of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (Gleason </= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years
- Symptomatic cerebral metastases
- Any significant ophthalmologic abnormality
- Use of coumarins
- Pregnant or breast-feeding women
- Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372384
Contacts
| Contact: Please reference Study ID Number: ML25423 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Bulgaria | |
| Active, not recruiting | |
| Plovdiv, Bulgaria, 4000 | |
| Completed | |
| Sofia, Bulgaria, 1756 | |
| Active, not recruiting | |
| Sofia, Bulgaria, 1404 | |
| Completed | |
| Sofia, Bulgaria, 1431 | |
| Terminated | |
| Sofia, Bulgaria, 1527 | |
| Completed | |
| Stara Zagora, Bulgaria, 8000 | |
| Terminated | |
| Varna, Bulgaria, 9010 | |
| Active, not recruiting | |
| Varna, Bulgaria, 9002 | |
| Recruiting | |
| Veliko Tarnovo, Bulgaria, 5000 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01372384 History of Changes |
| Other Study ID Numbers: | ML25423 |
| Study First Received: | June 10, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | to: be added |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Mitogens Erlotinib Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013