A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Patients With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01174563
First received: August 2, 2010
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in patients with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Patients will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression 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: | A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival according to grade of rash; tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST criteria [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Rate of Tarceva dose reductions due to grade III-IV rash [ Time Frame: approximately 3 years ] [ Designated as safety issue: Yes ]
- Progression-free survival in patients with Tarceva dose reductions due to grade III-IV rash; tumor assessments by CT or MRI according to RECIST criteria [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: erlotinib [Tarceva]
150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol
|
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
- Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small cell lung cancer (NSCLC)
- Presence of epidermal growth factor receptor (EGFR) mutations
- Previously untreated with any systemic anti-neoplastic therapy for advanced disease
- Last dose of a prior systemic anti-neoplastic therapy for early-stage disease >/= 4 weeks before study start, and patient recovered from acute toxicities of any previous therapy
Exclusion Criteria:
- Pregnant or breast feeding women
- Known allergy or other adverse reaction to study drug or any other related compound
- Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy)
- Newly diagnosed or not yet definitively treated (i.e. stable disease >/= 2 months) CNS metastases or spinal cord compression
- Any significant ophthalmological abnormality, especially those likely to increase the risk of corneal epithelial lesions (the use of contact lenses is not recommended during the study)
- Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174563
Contacts
| Contact: Reference Study ID Number: ML25200 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Locations
| Israel | |
| Recruiting | |
| Afula, Israel, 18101 | |
| Recruiting | |
| Ashkelon, Israel, 78278 | |
| Recruiting | |
| Beer Sheva, Israel, 8410101 | |
| Recruiting | |
| Haifa, Israel, 34362 | |
| Recruiting | |
| Haifa, Israel, 34354 | |
| Recruiting | |
| Holon, Israel, 58100 | |
| Recruiting | |
| Jerusalem, Israel, 91120 | |
| Recruiting | |
| Jerusalem, Israel, 91031 | |
| Recruiting | |
| Kfar Saba, Israel, 44281 | |
| Recruiting | |
| Nahariya, Israel, 22100 | |
| Recruiting | |
| Ramat-Gan, Israel, 52621 | |
| Recruiting | |
| Rehovot, Israel, 76100 | |
| Recruiting | |
| Sefad, Israel, 13100 | |
| Recruiting | |
| Tel Aviv, Israel, 64239 | |
| Recruiting | |
| Tiberias, Israel, 15208 | |
| Completed | |
| Zerifin, Israel, 70300 | |
Sponsors and Collaborators
Hoffmann-La Roche
Clalit Health Services
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01174563 History of Changes |
| Other Study ID Numbers: | ML25200 |
| Study First Received: | August 2, 2010 |
| Last Updated: | May 23, 2013 |
| Health Authority: | Israel: Minisrty of Health |
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 Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013