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)
NCT ID: NCT00777309
Last Updated: 2013-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
167 participants
INTERVENTIONAL
2008-09-30
2011-08-31
Brief Summary
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Detailed Description
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A total of 154 patients will be enrolled.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Erlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily.
ARQ 197
360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met
Erlotinib
Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met.
2
Erlotinib (150 mg) once daily plus ARQ 197 placebo twice daily
Erlotinib
Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met.
Placebo
The placebo is provided as a capsule
Interventions
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ARQ 197
360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met
Erlotinib
Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met.
Placebo
The placebo is provided as a capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
11. Previously diagnosed grade 3 or 4 (CTCAE) bradycardia or other heart arrhythmia
12. Any other significant co-mormid condition that, in opinion of the Investigator, would impair study participation or cooperation
13. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
18 Years
ALL
No
Sponsors
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ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
INDUSTRY
Responsible Party
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Locations
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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
Worcester, Massachusetts, United States
Charlotte, North Carolina, United States
Canton, Ohio, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Gauting, , Germany
Großhansdorf, , Germany
Hamburg, , Germany
Mainz, , Germany
Mannheim, , Germany
Villingen-Schwenningen, , Germany
Daugavpils, , Latvia
Riga, , Latvia
Bialystock, , Poland
Otwock, , Poland
Poznan, , Poland
Szczecin, , Poland
Torun, , Poland
Wroclaw, , Poland
Central Clinical Hospital #1
Moscow, , Russia
Central Clinical Hospital #2
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersgurg, , Russia
Lviv, , Ukraine
Countries
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Other Identifiers
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ARQ 197-209
Identifier Type: -
Identifier Source: org_study_id