Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second L… (NCT01126736) | Clinical Trial Compass
CompletedPhase 1/2
Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second Line Therapy in Patients With Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer
United States98 participantsStarted 2010-06-10
Plain-language summary
The purpose of this study is to determine whether Eribulin Mesylate Administered in Combination with Pemetrexed is safe and tolerable and to gain a preliminary indication of clinical benefit when administered to Patients with Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patient greater than or equal to 18 years of age;
✓. Histologically or cytologically confirmed nonsquamous NSCLC stage IIIB with malignant pleural effusion or stage IV disease not amenable to curative therapy. Patients with history of stage III disease that have relapsed after chemo- and radiotherapy are also eligible;
✓. Have at least 1 site of measurable disease by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) criteria;
✓. Have failed 1 prior platinum-doublet containing chemotherapy regimen for stage IIIB with malignant pleural effusion or 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.
✓. Life expectancy of greater than 3 months;
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) less than 1;
✓. Patients must have adequate renal function as evidenced by calculated creatinine clearance greater than 45 mL/min per the Cockcroft and Gault formula;
✓. Patients receiving daily treatment with non-steroidal anti-inflammatory agents (NSAIDS) are eligible. Patients with creatinine clearance 45-79 ml/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;
Exclusion criteria
✕. Prior treatment with pemetrexed, epothilone, ixabepilone, patupilone, halichondrin B or halichondrin B-like compounds;
What they're measuring
1
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Timeframe: Cycle 1 (cycle length=21 days)
2
Phase 1b: Percentage of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)
Timeframe: From date of first dose up to 30 days after the last dose of study drug in Phase 1b, up to approximately 1 year 2 months
3
Phase 2: Percentage of Participants Who Experienced TEAEs
Timeframe: From date of first dose up to 30 days after the last dose of study drug in Phase 2, up to approximately 3 years 6 months
✕. Received chemotherapy, targeted therapy, radiotherapy, surgery, or immunotherapy within the 30 days prior to commencing study treatment or have not recovered from all treatment-related toxicities to Grade less than 1, except for alopecia;
✕. 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, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for greater than 5 years;
✕. 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;
✕. Received treatment in another clinical study within the 30 days prior to commencing study treatment or patients who have not recovered from side effects of an investigational drug to Grade less than 1, except for alopecia;
✕. Are currently receiving any other treatment, including palliative radiotherapy for the tumor aside from control of symptoms;
✕. Common Toxicity Criteria (CTC) greater than Grade 3 peripheral neuropathy;
✕. Require therapeutic doses of vitamin K antagonists;