A Phase 1 Study of LY2787106 in Cancer and Anemia

Completed · Phase 1

Conditions studied: Anemia

In brief

This study will evaluate the safety LY2787106 in participants with cancer and anemia. It will also evaluate when LY2787106 can improve anemia. This study has two parts: Part A is a dose escalation evaluation. Part B is an evaluation of LY2787106 at a defined dose given with and without iron supplementation.

Key facts

Study ID: NCT01340976
Run by: Eli Lilly and Company
People needed: 33
Starts: 2010-01-01
Expected to finish: 2014-12-01
Last updated by the study team: 2018-10-03

Who can join

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

You may qualify if…

Have histological or cytological evidence of non-myeloid cancer (solid tumors, lymphomas or multiple myeloma) that is metastatic and/or incurable
Have been treated with at least one systemic (oral, intravenous, or subcutaneous) anti-cancer therapy or regimen
Have a hemoglobin of less than or equal to 11 grams/deciliter (g/dL)
Have a hepcidin level of greater than or equal to 5 nanograms/milliliter (ng/mL)
Have given written informed consent prior to any study-specific procedures
Have adequate hematologic, hepatic, and renal organ function
Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Available for the duration of the study and willing to follow study procedures
If male or female with reproductive potential: Must agree to use medically approved contraception during the trial and for 4 months following the last dose of study drug
If female with child bearing potential: Have a negative serum pregnancy test
Have an estimated life expectancy of greater than or equal to 12 weeks

You may not qualify if…

Have received treatment in the previous 21 days with, or have not recovered fully from, a drug that has not received regulatory approval for any indication
Have received erythropoiesis-stimulating agents in the previous 21 days or red blood cell transfusions in the previous 14 days, or in the investigator's opinion, likely to need red blood cell transfusion more frequently than every 21 days
Have received parenteral iron supplementation within the prior 14 days
Have a documented history of pure red cell aplasia, thalassemia major or sickle cell disease
Have a history of cirrhosis or major organ transplantation
QTc greater than 470 millisecond (msec)
Have evidence of clinically significant hemolysis or bleeding
Have a clinically significant systemic infection within 14 days of enrollment
Have a suspected or confirmed history of hemochromatosis.
Have other serious preexisting medical conditions (left to the discretion of the investigator)
Have symptomatic central nervous system malignancy or metastasis (screening not required)
Have acute or chronic leukemia
Are a female who is pregnant or lactating
Have a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (screening not required)
Have received external beam radiotherapy to more than 25% of the bone marrow
Have known clinically significant hypersensitivity to biologic agents
Have received live vaccine(s) within 1 month of screening or with plans of doing that during the participation to the study
Have a history of congestive heart failure with New York Heart Association (NYHA) Class greater than 2 (NYHA Class 1 and 2 are eligible), unstable angina or recent myocardial infarction (within 1 year prior to administration of study drug)

Where it is running

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. — La Jolla, California, 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. — Santa Monica, California, 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. — Indianapolis, Indiana, 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. — Philadelphia, Pennsylvania, 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. — Dallas, Texas, 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. — Houston, Texas, 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. — The Woodlands, Texas, 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. — Seattle, 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. — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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