A study comparing eribulin and pemetrexed versus pemetrexed alone for the treatment of advanced lung cancer
- Conditions
- Advanced Nonsquamous Non-Small Cell Lung CancerMedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-016047-19-CZ
- Lead Sponsor
- Eisai Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 145
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 <9.0 g/dL at Screening is acceptable if it is corrected to =9 g/dL by growth factor or transfusion prior to first dose), and platelet count =100 X 109/L;
10. Patients must have adequate liver function as evidenced by bilirubin =1.5 times the upper limit of the normal range (ULN), and alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2 X ULN (in the case of liver metastases, =3 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;
11. 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;
12. Females of childbearing potential must have a negative serum pregnancy test;
13. Females may not be breastfeeding
14. Ability to understand and willingness to sign a written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method