A Phase 1 Study of LY2787106 in Cancer and Anemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01340976
First received: January 28, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: LY2787106
Dietary Supplement: Iron Supplementation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion (estimate: 4 years) ] [ Designated as safety issue: Yes ]
  • Mean change in hemoglobin with or without oral iron supplementation [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Maximum concentration (Cmax) [ Time Frame: Days 1, 2 and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 and after last infusion on Weeks 1, 3 and 9 and/or study completion ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the curve (AUC) [ Time Frame: Days 1, 2 and 4of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 and after last infusion on Weeks 1, 3 and 9, and/or study completion ] [ Designated as safety issue: No ]
  • Recommended dose for future studies: Maximum tolerated dose (MTD) [ Time Frame: Baseline to study completion (estimate: 4 years) ] [ Designated as safety issue: Yes ]
  • Change in serum iron [ Time Frame: First dose of study drug, study completion (estimate: 4 years) ] [ Designated as safety issue: No ]
  • Maximum change in reticulocyte count [ Time Frame: First dose of study drug, study completion (estimate: 4 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: November 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2787106 Dose Escalation
Part A: Dose escalation starting at 0.3 mg/kg, intravenously (IV), day one of up to three 21-day cycles.
Drug: LY2787106
Administered intravenously (IV).
Experimental: 10 mg/kg LY2787106
Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.
Drug: LY2787106
Administered intravenously (IV).
Experimental: 10 mg/kg LY2787106+Iron
Part B: 10 mg/kg of LY2787106, administered IV, on day one of up to eight 7-day cycles with daily oral iron supplementation. Participants who do not experience a stopping rule and who are felt to be benefiting during the defined treatment period may receive additional doses at the discretion of the investigator.
Drug: LY2787106
Administered intravenously (IV).
Dietary Supplement: Iron Supplementation
Administered orally.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340976

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United States, California
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. Recruiting
La Jolla, California, United States, 92093
Contact: Eli Lilly         
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. Recruiting
Santa Monica, California, United States, 90404
Contact: Eli Lilly         
United States, Indiana
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. Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Eli Lilly         
United States, Pennsylvania
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. Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Eli Lilly         
United States, Texas
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. Recruiting
Dallas, Texas, United States, 75246
Contact: Eli Lilly         
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. Recruiting
Houston, Texas, United States, 77030
Contact: Eli Lilly         
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. Recruiting
The Woodlands, Texas, United States, 77380
Contact: Eli Lilly         
United States, Washington
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. Recruiting
Seattle, Washington, United States, 98109
Contact: Eli Lilly         
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. Recruiting
Vancouver, Washington, United States, 98684
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01340976     History of Changes
Other Study ID Numbers: 13131, I3S-MC-JABA
Study First Received: January 28, 2011
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Cancer Related Anemia

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014