Advanced Nonsquamous Non-Small Cell Lung Cancer MedDRA version: 14.1 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: 14.1 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) MedDRA version: 14.1 Level: PT Classification
Conditions
Interventions
Product Name: Eribulin mesylate
Product Code: E7389
Pharmaceutical Form: Injection
INN or Proposed INN: Eribulin
CAS Number: 441045-17-6
Current Sponsor code: E7389
Other descriptive name: ER-086526
Sponsors
Eisai Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient >=18 years of age; 2. Histologically or cytologically confirmed nonsquamous 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) and not amenable to curative therapy. Patients with history of stage III disease that have relapsed after chemo- and radiotherapy are also eligible; 3. Have at least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) criteria; 4. Have failed 1 prior platinum-doublet containing chemotherapy regimen for stage IV nonsquamous NSCLC. One additional cytotoxic regimen is allowed for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy for Phase II patients. For patients enrolled in the Phase Ib portion, a maximum of three total prior regimens is allowed. 5. Life expectancy of =3 months; 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =1; 7. Patients must have adequate renal function as evidenced by calculated creatinine clearance =45 mL/min per the Cockcroft and Gault formula; 8. Patients receiving daily treatment with non-steroidal anti-inflammatory agents (NSAIDS) are eligible. Patients with creatinine clearance 45-79ml/min must be able to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed; 9. Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) =1.5 X 109/L, hemoglobin =9.0 g/dL (a hemoglobin =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Prior treatment with pemetrexed, epothilone, ixabepilone, patupilone, or halichondrin B or halichondrin B-like compounds; 2. History of other malignancies except: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, or b) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for =3 years; 3. 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; 4. Received chemotherapy, biological therapy, hormonal therapy, targeted therapy, or radiotherapy within 30 days prior to commencing study treatment, or have not recovered from all treatment-related toxicities to Common Toxicity Criteria (CTC) Grade =1, except for peripheral neuropathy (Grade 1 or 2 are permitted) or alopecia; 5. Are currently receiving any other systemic anticancer treatment, including palliative radiotherapy; 6. Uncontrolled clinically significant pleural effusions, ascites, or other third space fluid collections; 7. Uncontrolled diabetes mellitus Type 1 or 2; 8. Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association (NYHA) Grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia); 9. Subjects with a high probability of Long QT Syndrome; 10. Patients with organ allografts requiring immunosuppression; 11. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive; 12. Hypersensitivity to halichondrin B and/or halichondrin B chemical derivative; or 13. Have any medical condition that would interfere with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase Ib: to define the maximum tolerated dose (MTD)/dose recommended for Phase II of eribulin mesylate, hereafter referred to as eribulin, in each of two dosing schedules, administered in combination with pemetrexed in patients with nonsquamous, non-small cell lung cancer (NSCLC), previously treated with 1 cytotoxic chemotherapy regimen for stage IIIB or IV disease. Phase II: to evaluate the safety and tolerability of multiple doses of eribulin administered in combination with pemetrexed, compared with pemetrexed alone as second-line therapy in patients with advanced nonsquamous NSCLC.;Secondary Objective: Phase II: to make a preliminary assessment of the efficacy of eribulin administered in combination with pemetrexed, compared with pemetrexed alone as second-line therapy in patients with advanced nonsquamous NSCLC. Efficacy will be evaluated by median progression-free survival (PFS), proportion of PFS at Week 12, time to progression (TTP), overall survival (OS), and overall response rate (ORR).;Primary end point(s): The primary exploratory efficacy endpoint will be the median progression-free survival (PFS), within treatment group, defined as the time from the date of randomization of a patient until the sooner of (1) the date of first documented progression of such patient’s disease based on Investigator assessments according to RECIST or (2) the date of such patient’s death due to any cause.;Timepoint(s) of evaluation of this end point: Date of first documented progression of such patient’s disease based on Investigator assessments according to RECIST or (2) the date of such patient’s death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary exploratory efficacy endpoints include proportion of PFS at Week 12, median TTP, OS, and ORR, within treatment group.;Timepoint(s) of evaluation of this end point: Week 12 for proportion of PFS | — |
Countries
Czech Republic, Germany, Italy, Ukraine, United States
Contacts
Public ContactMedical Information
Eisai Ltd
Outcome results
None listed