|Phase II||Treatment||Closed||18 and over||Pharmaceutical / Industry||14242|
The purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in patients with extensive-stage disease small cell lung cancer (SCLC)
- histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma
- measurable disease as defined by the New Response Evaluation Criteria in Solid Tumors (RECIST): Revised RECIST Guideline (version 1.1)
- no prior systemic chemotherapy, immunotherapy, biological, hormonal, or investigational therapy for SCLC
- a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
- adequate organ function, including:
- hematologic: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to (≥)1.5 x 10^9/ liter (L), platelets ≥100 x 10^9/L, and hemoglobin ≥9 grams per deciliter (g/dL).
- hepatic: bilirubin less than or equal to (≤)1.5 times upper limits of normal (ULN), and alkaline phosphatase (AP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times ULN (AP, AST, and ALT ≤5 times ULN is acceptable if liver has tumor involvement
- renal: calculated creatinine clearance (CrCl) ≥45 milliliters per minute (mL/min) based on the standard Cockcroft and Gault formula
- For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation), post-menopausal (at least 12 consecutive months of amenorrhea), or compliant with a medically approved contraceptive regimen (intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
- estimated life expectancy of at least 12 weeks
- written informed consent prior to any study-specific procedures
- able and willing to learn to self-administer LY2510924, or have a caregiver who is willing to learn and able to administer LY2510924 by subcutaneous (SC) injection
- currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- prior treatment with carboplatin/etoposide or LY2510924
- any concurrent administration of any other antitumor therapy
- diagnosis of non-small cell lung cancer (NSCLC) or mixed NSCLC and small cell lung cancer (SCLC)
- no prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score ≤6) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry
- serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the study requirements
- active or ongoing infection during screening requiring the use of systemic antibiotics
- serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease as defined by the New York Heart Association Class III or IV
- clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously- treated central nervous system (CNS) metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug.
- known or suspected allergy to any agent given in association with this trial
- pregnant or lactating women
Trial Lead Organizations/Sponsors
Eli Lilly and Company
|Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01439568
ClinicalTrials.gov processed this data on December 11, 2013
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