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A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)


Inclusion Criteria:



Patients must meet the following criteria for study entry:

- Histologically confirmed NSCLC

- Availability of a tumor specimen

- Recurrent or progressive disease following at least one chemo containing regimen for
Stage IIIB/IV disease

- Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors
(RECIST)

- At least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose−positron
emission tomography (FDG-PET) scan that is also a target lesion on computed
tomography (CT) according to RECIST

Exclusion Criteria:

- More than two prior treatments for Stage IIIB/IV

- More than 30 days of exposure to an investigational or marketed agent that can act by
EGFR inhibition, or a known epidermal growth factor receptor (EGFR)-related toxicity
resulting in dose modifications

- Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days
prior to randomization

- Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids
for symptomatic control) central nervous system (CNS) metastasis

- History of serious systemic disease within the past 6 months prior to randomization

- Uncontrolled diabetes

- Major surgical procedure or significant traumatic injury within 28 days prior to
randomization

- Anticipation of need for a major surgical procedure during the course of the study

- Local palliative radiotherapy within 7 days prior to randomization or persistent
adverse effects from radiotherapy that have not been resolved to Grade II or less
prior to randomization

- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).

Outcome Time Frame:

Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)

Safety Issue:

No

Principal Investigator

Premal Patel, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

OAM4558g

NCT ID:

NCT00854308

Start Date:

April 2009

Completion Date:

January 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Tarceva
  • Lung Cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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