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A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01439568•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in participants with extensive-stage disease small cell lung cancer (SCLC)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

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. Participants 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 participant'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
+1 more criteria

Locations (15)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Denver, Colorado, United States

Fort Myers, Florida, United States

Orlando, Florida, United States

Pensacola, Florida, United States

Chicago, Illinois, United States

Bethesda, Maryland, United States

Springfield, Missouri, United States

Omaha, Nebraska, United States

Cincinnati, Ohio, United States

Greenville, South Carolina, United States

Key Dates

Start Date

September 1, 2011

Primary Completion Date

January 1, 2014

Completion Date

August 1, 2016

Last Updated

July 23, 2019

Enrollment

ACTUAL participants

Conditions

Extensive Stage Small Cell Lung Carcinoma

Interventions

LY2510924

DRUG

Carboplatin

DRUG

Etoposide

DRUG

Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

NCT03672773

Recurrent Extensive Stage Small Cell Lung CarcinomaRefractory Extensive Stage Small Cell Lung Carcinoma

View study

COMPLETEDPHASE1/PHASE2

Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer

NCT01737502

Extensive Stage Small Cell Lung CarcinomaLung Adenocarcinoma+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer

Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

MK-3475 as Maintenance Therapy in Extensive Stage SCLC

Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer