Clinical trial NCT01340976: A Phase 1 Study of LY2787106 in Cancer and Anemia
Official title: A Phase 1 Safety Study of LY2787106 in Patients With Cancer and Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia
Keywords: Cancer Related Anemia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-04-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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 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

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 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)

Primary outcomes:
measure: Number of Participants With Clinically Significant Events
timeFrame: Baseline to Study Completion (up to 5 Years)
measure: Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation
timeFrame: Baseline, Cycle 4 (7-day cycle)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax)
timeFrame: Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion
measure: PK: Area Under the Curve (AUC[0-∞])
timeFrame: Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion
measure: Recommended Dose for Future Studies: Maximum Tolerated Dose (MTD)
timeFrame: Baseline to Cycle 1 of Part A
measure: Change From Baseline in Serum Iron
timeFrame: Baseline, Cycle 4 (7-day cycle)
measure: Mean Change From Baseline in Reticulocyte Count
timeFrame: Baseline, Cycle 4 (7-day cycle)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: 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.
state: California
city: Santa Monica
country: United States
facility: 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.
state: California
city: Indianapolis
country: United States
facility: 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.
state: Indiana
city: Philadelphia
country: United States
facility: 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.
state: Pennsylvania
city: Dallas
country: United States
facility: 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.
state: Texas
city: Houston
country: United States
facility: 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.
state: Texas
city: The Woodlands
country: United States
facility: 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.
state: Texas
city: Seattle
country: United States
facility: 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.
state: Washington
city: Vancouver
country: United States
facility: 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.
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Vadhan-Raj S, Abonour R, Goldman JW, Smith DA, Slapak CA, Ilaria RL Jr, Tiu RV, Wang X, Callies S, Cox J, Tuttle JL, Lau YK, Roeland EJ. A first-in-human phase 1 study of a hepcidin monoclonal antibody, LY2787106, in cancer-associated anemia. J Hematol Oncol. 2017 Mar 21;10(1):73. doi: 10.1186/s13045-017-0427-x.