A Study of LY2510924 in Patients With Extensive-Stage Small Cell Lung Carcinoma



Status:Active, not recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2011
End Date:December 2016

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A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma

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)


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
15
sites
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Richmond, VA
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Bethesda, MD
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Chattanooga, TN
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Chicago, IL
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Cincinnati, OH
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Denver, CO
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Fort Myers, FL
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Fort Worth, TX
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Greenville, South Carolina 29605
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Greenville, SC
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Memphis, TN
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Nashville, TN
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Omaha, NE
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Orlando, FL
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Pensacola, FL
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Springfield, MO
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