A Study of LY2940680 in Small Cell Lung Cancer

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Small Cell Lung Carcinoma

In brief

The purpose of this study is to find a recommended dose of LY2940680 that can be safely given in combination with etoposide and carboplatin followed by LY2940680 alone in participants with extensive-disease small cell lung cancer. The study will also compare progression-free survival in participants who are administered etoposide, carboplatin and LY2940680 followed by LY2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.

Key facts

Study ID

NCT01722292

Run by

Eli Lilly and Company

People needed

26

Starts

2013-01-01

Expected to finish

2015-02-01

Last updated by the study team

2018-12-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological diagnosis of Small Cell Lung Cancer (SCLC), including malignant pleural effusion that is extensive stage per the International Staging System
• Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule
• No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC
• Prior radiation therapy allowed to <25% of the bone marrow. Participants who have received prior radiation to the whole pelvis or chest for the treatment of SCLC are not eligible
• At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Adequate organ function including the following:
• Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1.5 x 10\^9/ liter (L), platelets ≥100 x 10\^9/L, and hemoglobin ≥9 grams/deciliter (g/dL)
• Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), Serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3.0 x ULN (AP, AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement)
• Renal: calculated creatinine clearance (CrCl) ≥50 milliliters per minute (mL/min) based on the standard Cockcroft and Gault formula
• Estimated life expectancy of at least 12 weeks
• For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period
• Availability of a tumor tissue sample
• Able to swallow capsules

You may not qualify if…

• 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
• Have previously participated in a study involving LY2940680
• Have previously received treatment with carboplatin or etoposide
• Have a mixed histological diagnosis of SCLC and Non-Small Cell Lung Cancer (NSCLC)
• Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol
• Have an active infection [≥38.5 degrees Celsius and/or receiving Intravenous (IV) antibiotic therapy]
• Have a serious cardiac condition
• Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Participants with a history of non-metastatic prostate cancer, including biochemical relapse only, will be eligible even if diagnosed less than 5 years previously
• Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the participant must be stable after radiotherapy for ≥2 weeks and off of corticosteroids for ≥1 week
• Presence of clinically significant third-space fluid collections that cannot be controlled prior to study entry
• Significant weight loss (that is, ≥10%) over the 6-week period prior to study entry
• Concurrent administration of any other antitumor therapy. An exception will be made for non-metastatic prostate cancer participants continuing androgen blockade therapy only or breast cancer participants continuing adjuvant antiestrogen therapy only (for example, an aromatase inhibitor)
• Females who are breastfeeding
• Have corrected QT interval (QTc) of >470 millisecond (msec) on screening electrocardiogram (ECG)
• Have received medications that are strong inhibitors of Cytochrome P450 3A4 (CYP3A4) within 7 days prior to receiving study drug

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• New York Oncology Hematology Associate — Albany, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Clinical Research Unit (ITOR) Greenville Hospital System — Greenville, South Carolina, United States
• Accelerated Comm. Oncology Research Network (ACORN) — Memphis, Tennessee, United States
• The West Clinic — Memphis, Tennessee, United States
• US Oncology — The Woodlands, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Northwest Cancer Specialists PC — Vancouver, Washington, United States
• Yakima Valley Memorial Hospital — Yakima, Washington, United States
• 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. — London, United Kingdom
• 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. — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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