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A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Anemia

Thank you

Trial Information

A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia


Inclusion Criteria:



- 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 g/dL

- Have a hepcidin level of greater than or equal to 5 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

Exclusion Criteria:

- 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 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of participants with clinically significant effects

Outcome Time Frame:

Baseline to study completion (estimate: 4 years)

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13131

NCT ID:

NCT01340976

Start Date:

November 2009

Completion Date:

July 2014

Related Keywords:

  • Anemia
  • Cancer Related Anemia
  • Anemia

Name

Location

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. Durham, North Carolina  
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. Greenbrae, California  94904
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. Athens, Georgia  30607
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  46227
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. Dunmore, Pennsylvania  18512
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. Bedford, Texas  76022
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  98133