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A Study of Tarceva (Erlotinib) in Patients With Advanced and/or Metastatic Non-small Cell Lung Cancer With EGFR Positive Mutation (BIOTEC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01153984
First received: June 16, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This open-label, single-arm, multi-center study will evaluate the effect of Tarc eva (erlotinib) on progression-free survival and the incidence and type of bioma rkers in patients with advanced and/or metastatic non-small cell lung cancer wit h Epidermal Growth Factor Receptor (EGFR) positive mutations. Eligible patients will receive Tarceva 150mg po daily. The anticipated time on study treatment is until progression or unacceptable toxicity.


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: Biomarkers Impact On the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Positive Mutation - BIOTEC

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Evaluation of progression-free survival by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From baseline until 40 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of time to disease progression by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From baseline up to 40 months ] [ Designated as safety issue: No ]
  • Evaluation of objective response rate by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From baseline up to 40 months ] [ Designated as safety issue: No ]
  • Evaluation of 1-year survival rate by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From baseline up to 40 months ] [ Designated as safety issue: No ]
  • Assessment of the localization of disease progression by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From baseline up to 40 months ] [ Designated as safety issue: No ]
  • Evaluation of patient's profile based on gender, age, incidence of mutations, smoking status [ Time Frame: From baseline up to 40 months ] [ Designated as safety issue: No ]
  • Collection of local epidemiological data [ Time Frame: At Screening (prior to Day-14) and at Baseline (Day-14 to -1) ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
erlotinib [Tarceva] 150mg po 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
  • Histological documented adenocarcinoma, locally advanced - stage IIIB, metastatic - stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Life expectancy >=12 weeks
  • Evidence of disease with at least one measurable disease criteria as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST)
  • Adequate haematological, liver and renal function

Exclusion Criteria:

  • Known hypersensitivity to erlotinib or any of its excipients
  • Squamous non-small cell or small cell tumors or absence of histological report
  • Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
  • Prior exposure to inhibitors of Epidermal Growth Factor Receptor (EGFR)
  • Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the patient's current stage of disease
  • Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögrens syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
  • Radical radiotherapy with curative intent within 28 days prior to enrolment
  • Any active non-controlled systemic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153984

Locations
Romania
Alba Iulia, Romania, 510073
Bucharest, Romania, 04195
Bucharest, Romania, 050098
Bucharest, Romania, 022338
Bucuresti, Romania, 022328
Cluj-Napoca, Romania, 400015
Iasi, Romania, 6600
Timisoara, Romania, 300239
Timisoara, Romania, 300167
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: NCT01153984     History of Changes
Other Study ID Numbers: ML22606, 2009-017063-42
Study First Received: June 16, 2010
Last Updated: November 3, 2014
Health Authority: Romania: National Medicines Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014