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

Brief Summary

Official Title: “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)

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: January 2014

Interventions Used in this Clinical Trial

  • Drug: LY2510924
    • Administered subcutaneous injection
  • Drug: Carboplatin
    • Administered intravenously
  • Drug: Etoposide
    • Administered intravenously

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: LY2510924 + Carboplatin + Etoposide
    • LY2510924: 20 milligram (mg) administered once daily as a subcutaneous injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
  • Active Comparator: Carboplatin + Etoposide
    • Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.

Outcome Measures for this Clinical Trial

Primary Measures

  • Progression Free Survival
    • Time Frame: Baseline to measured progressive disease or date of death from any cause (estimate 2 years)
      Safety Issue?: No

Secondary Measures

  • Number of participants achieving an objective Tumor response, (Objective Response Rate)
    • Time Frame: Baseline to date of tumor response or measured progressive disease or date of death from any cause (estimate 2 years)
      Safety Issue?: No
  • Overall Survival
    • Time Frame: Baseline to date of death from any cause (estimate 2 years)
      Safety Issue?: No
  • Duration of Overall Response
    • Time Frame: Date of response to date of progressive disease (estimate 2 years)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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, Eli Lilly and Company

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01439568