A Phase 1 Study of LY2787106 in Cancer and Anemia

Lilly

Status and phase: Completed; Phase 1

Conditions: Anemia

Treatments: Drug: LY2787106; Dietary Supplement: Iron Supplementation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340976

13131

I3S-MC-JABA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

LY2787106 Dose Escalation

Experimental group

Description:

Part A: Dose escalation starting at 0.3 milligram/kilogram (mg/kg), intravenously (IV), day one of up to three 21-day cycles.

Treatment:

Drug: LY2787106

10 mg/kg LY2787106

Experimental group

Description:

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.

Treatment:

Drug: LY2787106

10 mg/kg LY2787106+Iron

Experimental group

Description:

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.

Treatment:

Drug: LY2787106

Dietary Supplement: Iron Supplementation