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Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)

NCT01244191•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous non-small-cell lung cancer.
•Measurable disease and documented disease progression following last prior therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
•Have received one or two prior lines of systemic anti-cancer therapy therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy. Patients who received only adjuvant treatment will be eligible only if disease progression occurred \<6 months after completion of adjuvant therapy. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Resolution of any toxic effects of prior therapy (including radiotherapy) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, Grade ≤1 (with the exception of alopecia and ≤grade 2 neuropathy). Subject must have recovered from significant surgery-related complications.
•Demonstrate adequate bone marrow, liver, and renal functions, defined as:
•ALT, AST, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) in subjects with no liver metastasis and ≤5.0 x ULN in subjects with liver metastasis.
•Total bilirubin ≤ 1.5 × ULN (≤ 4 × ULN total and ≤1.5 × ULN direct bilirubin is acceptable for subjects with Gilbert's syndrome).
•ANC ≥1.5 × 10\^9/L.
•Platelet count ≥100 × 10\^9/L.
+6 more criteria

Exclusion Criteria

•Prior therapy with an EGFR inhibitor and/or ARQ 197 (or other known c-MET inhibitor).
•Receipt of any systemic anti-tumor treatment for NSCLC within 3 weeks prior to randomization.
•Receipt of palliative radiotherapy within 2 weeks or radiotherapy for curative intent of target lesions within 3 weeks prior to randomization. Lesions subjected to radiotherapy within 3 weeks prior to randomization may not be used as target lesions.
•Major surgical procedure within 3 weeks prior to randomization.
•History of cardiac disease:
•Congestive heart failure defined as Class II to IV per New York Heart Association classification; active coronary artery disease; previously diagnosed symptomatic bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are allowed) or other cardiac arrhythmia defined as ≥Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred \> 6 months prior to study entry is permitted).
•Clinically unstable central nervous system (CNS) metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by MRI or computed tomography (CT) scan within 4 weeks of randomization and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications).
•Need to breastfeed a child during or within 12 weeks of completing the study.
•Significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of ARQ 197 and/or erlotinib (eg, Crohn's disease, small or large bowel resection, malabsorption syndrome).
•Inability or unwillingness to swallow the complete doses of ARQ 197 or erlotinib.
+4 more criteria

Locations (304)

Tucson, Arizona, United States

Los Angeles, California, United States

Oxnard, California, United States

Rancho Mirage, California, United States

Santa Monica, California, United States

Aurora, Colorado, United States

Key Dates

Start Date

January 11, 2011

Primary Completion Date

December 15, 2012

Completion Date

December 15, 2012

Last Updated

April 6, 2021

Enrollment

1,048

ACTUAL participants

Conditions

Non Squamous, Non-small-cell Lung Cancer

Interventions

Tivantinib

DRUG

Placebo

DRUG

Erlotinib

DRUG