A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) versus BSC Alone in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens

Eisai Inc.0 sites135 target enrollmentSeptember 7, 2011

Conditionsocally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)MedDRA version: 15.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ocally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
Sponsor: Eisai Inc.
Enrollment: 135
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 7, 2011

End Date

June 27, 2015

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Eisai Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Age \=18 years;
•2\. Patients with histologically or cytologically confirmed non\-squamous NSCLC with locally advanced or metastatic disease based on Tumor, Node, Metastasis (TNM) staging according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Seventh Edition, who have failed at least 2 lines of systemic anticancer therapy for advanced or metastatic NSCLC (does not include adjuvant chemotherapy); In countries where erlotinib is approved and marketed for the treatment of NSCLC, patients must have received erlotinib (or gefitinib for patients outside of the US) for their NSCLC if they have known EGFR activating mutations. Patients of unknown EGFR status who have not received prior erlotinib (or gefitinib) should be tested for EGFR activating mutations prior to study entry. In countries where crizotinib is approved and marketed, patients must have received crizotinib treatment for NSCLC that is anaplastic lymphoma kinase (ALK)\-positive. Patients with ALK\-positive NCSLC or patients with KRAS mutations are not required to have prior treatment with erlotinib or gefitinib;
•3\. Patients must have at least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1\.1 (RECIST v.1\.1\);
•4\. ECOG PS of 0 to 2;
•5\. Patients must have adequate renal function as evidenced by serum creatinine \=1\.5 X upper limit of normal (ULN) or calculated creatinine clearance \=30 mL/min per the Cockcroft and Gault formula;
•6\. Blood pressure must be well\-controlled (\<140/90 mm Hg at Screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy;
•7\. Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) \=1\.5 X 109/L, hemoglobin \=9\.0 g/dL, and platelet count \=100 X 109/L;
•8\. Patients must have adequate liver function as evidenced by bilirubin \=1\.5 times the ULN, and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \=3 X ULN (in the case of liver metastases, \=5 X ULN). If there are bone metastases, liver\-specific alkaline phosphatase may be separated from the total and used to assess liver function instead of total alkaline phosphatase;
•9\. Patients must have adequate coagulation system function as defined by prothrombin time/International normalized ratio (INR) \=1\.5 X ULN. Patients requiring INR monitoring are excluded. Low molecular weight heparin is allowed;
•10\. 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;

Exclusion Criteria

•1\. Prior therapy with E7080 or other small molecule vascular endothelial growth factor inhibitors;
•2\. Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
•3\. Meningeal carcinomatosis;
•4\. Received chemotherapy, targeted therapy, radiotherapy, surgery, or immunotherapy within the 21 days prior to commencing study treatment or have not recovered from all treatment\-related toxicities to Grade \=2, except for alopecia;
•5\. Received treatment with another investigational agent within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade \=2, except for alopecia;
•6\. Patients with proteinuria \>1\+ on urine dipstick testing will undergo 24\-hour urine collection for quantitative assessment of proteinuria. Patients with 24\-hour urine protein \=1 g/24 hours will be ineligible;
•7\. Serious non\-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within the 28 days prior to commencing study treatment. Minor surgery such as Portacath placement or skin biopsy is permitted if \=7 days have passed;
•8\. Major surgery scheduled during the projected course of the study;
•9\. History of bleeding diathesis or coagulopathy;
•10\. Active hemoptysis (defined as bright red blood of a half teaspoon or more) within the 30 days prior to study entry;