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)
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| ClinicalTrials.gov Identifier: NCT00777309 |
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Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : February 28, 2013
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Sponsor:
ArQule
Information provided by (Responsible Party):
ArQule
- Study Details
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer | Drug: ARQ 197 Drug: Erlotinib Drug: Placebo | Phase 2 |
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. The study will evaluate progression-free survival between the two arms.
A total of 154 patients will be enrolled.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 167 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | May 2011 |
| Actual Study Completion Date : | August 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Erlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily.
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Drug: ARQ 197
360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met
Other Name: Tivantinib Drug: 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.
Other Name: Tarceva |
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Active Comparator: 2
Erlotinib (150 mg) once daily plus ARQ 197 placebo twice daily
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Drug: 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.
Other Name: Tarceva Drug: Placebo The placebo is provided as a capsule |
Primary Outcome Measures :
- Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo
Secondary Outcome Measures :
- Evaluate overall survival (OS)
- Overall response rate (ORR)
- Safety of ARQ 197 in combination with erlotinib in patients with NSCLC
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provide signed and dated informed consent prior to study-specific screening procedures
- ≥ 18 years old
- Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
- ≥ one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have included erlotinib or other EGFR inhibiting agent)
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- 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
- Females of childbearing potential must have a negative serum pregnancy test
- Good organ function
- 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:
- Previous receipt of erlotinib or other EGFR inhibiting therapy
- Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for radiotherapy) prior to the start of designated treatment
- Documented major surgical procedure within 4 weeks prior to randomization.
- 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
- Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
- 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)
- Unable or unwilling to swallow the complete dose of erlotinib or ARQ 197
- Any known contraindication to treatment with ARQ 197 or erlotinib
- Any known hypersensitivity to any of component of ARQ 197 or erlotinib
- 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
- Previously diagnosed grade 3 or 4 (CTCAE) bradycardia or other heart arrhythmia
- Any other significant co-mormid condition that, in opinion of the Investigator, would impair study participation or cooperation
- Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777309
Locations
| United States, California | |
| Burbank, California, United States, 91505 | |
| Santa Monica, California, United States, 90404 | |
| United States, Connecticut | |
| Torrington, Connecticut, United States, 06790 | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32204 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Batesville, Indiana, United States, 47006 | |
| Indianapolis, Indiana, United States, 46107 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| Worcester, Massachusetts, United States, 01608 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Canton, Ohio, United States, 44718 | |
| United States, Texas | |
| Corpus Christi, Texas, United States, 78410 | |
| Dallas, Texas, United States, 75246 | |
| Dallas, Texas, United States, 75390 | |
| Houston, Texas, United States, 77024 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84114 | |
| Germany | |
| Gauting, Germany, 82131 | |
| Grosshansdorf, Germany, 22927 | |
| Hamburg, Germany, 21075 | |
| Mainz, Germany, 55131 | |
| Mannheim, Germany, 68167 | |
| Villingen-Schwenningen, Germany, 78050 | |
| Latvia | |
| Daugavpils, Latvia, 5420 | |
| Riga, Latvia, 1002 | |
| Poland | |
| Bialystock, Poland, 15-027 | |
| Otwock, Poland, 05-400 | |
| Poznan, Poland, 60-569 | |
| Szczecin, Poland, 70-891 | |
| Torun, Poland, 87-100 | |
| Wroclaw, Poland, 53-439 | |
| Russian Federation | |
| Central Clinical Hospital #1 | |
| Moscow, Russian Federation, 125367 | |
| Central Clinical Hospital #2 | |
| Moscow, Russian Federation, 129128 | |
| St. Petersburg, Russian Federation, 197002 | |
| St. Petersburg, Russian Federation, 197089 | |
| St. Petersgurg, Russian Federation, 197758 | |
| Ukraine | |
| Lviv, Ukraine, 79031 | |
Sponsors and Collaborators
ArQule
| Responsible Party: | ArQule |
| ClinicalTrials.gov Identifier: | NCT00777309 |
| Other Study ID Numbers: |
ARQ 197-209 |
| First Posted: | October 22, 2008 Key Record Dates |
| Last Update Posted: | February 28, 2013 |
| Last Verified: | February 2013 |
Keywords provided by ArQule:
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NSCLC |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |