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A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

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A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Randomized Phase 2 Study of Erlotinib Plus ARQ 197 Versus Erlotinib Plus Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT00777309•ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

View on ClinicalTrials.gov

Summary

This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.

Detailed Description

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provide signed and dated informed consent prior to study-specific screening procedures
•2. ≥ 18 years old
•3. Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
•4. ≥ one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have included erlotinib or other EGFR inhibiting agent)
•5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
•6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
•7. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
•8. Females of childbearing potential must have a negative serum pregnancy test
•9. Good organ function
•10. Confirmed availability of archival pathology samples (10 unstained paraffin-embedded slides) or tissue block suitable for subsequent analysis of KRAS, EGFR, and c-Met

Exclusion Criteria

•1. Previous receipt of erlotinib or other EGFR inhibiting therapy
•2. Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for radiotherapy) prior to the start of designated treatment
•3. Documented major surgical procedure within 4 weeks prior to randomization.
•4. Symptomatic central nervous system metastases either considered in the opinion of investigator to be clinically unstable or which require steroids, anti-epileptics, or other symptom-relieving medications
•5. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
•6. Significant gastrointestinal disorder that, in opinion of Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn's disease, small or large bowel resection, malabsorbtion syndrome)
•7. Unable or unwilling to swallow the complete dose of erlotinib or ARQ 197
•8. Any known contraindication to treatment with ARQ 197 or erlotinib
•9. Any known hypersensitivity to any of component of ARQ 197 or erlotinib
•10. Other malignancy within 5 years of randomization, with the exception of adequately treated intraepithelial carcinoma of the cervix uteri, prostate carcinoma with a PSA value \< 0.2 ng/ml or basal or squamous cell carcinoma of the skin
+3 more criteria

Locations (38)

Burbank, California, United States

Santa Monica, California, United States

Torrington, Connecticut, United States

Jacksonville, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Batesville, Indiana, United States

Indianapolis, Indiana, United States

Louisville, Kentucky, United States

Boston, Massachusetts, United States

Key Dates

Start Date

September 1, 2008

Primary Completion Date

May 1, 2011

Completion Date

August 1, 2011

Last Updated

February 28, 2013

Enrollment

167

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

ARQ 197

DRUG

Erlotinib

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

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