A Phase 1 Study of LY2787106 in Cancer and Anemia | NCT01340976

NCT01340976

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I3S-MC-JABA	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY2787106 Dose Escalation	Experimental	Part A: Dose escalation starting at 0.3 milligram/kilogram (mg/kg), intravenously (IV), day one of up to three 21-day cycles.	Drug: LY2787106
10 mg/kg LY2787106	Experimental	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
10 mg/kg LY2787106+Iron	Experimental	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 Dietary Supplement: Iron Supplementation

Name	Type	Description	Arm Group Labels	Other Names
LY2787106	Drug	Administered IV.	10 mg/kg LY2787106 10 mg/kg LY2787106+Iron LY2787106 Dose Escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Clinically Significant Events	Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.	Baseline to Study Completion (up to 5 Years)
Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation	This analysis assesses the mean change in Hemoglobin from baseline to the end of Cycle 4. The analysis was carried separately for Cohort B1 without supplemental iron and Cohort B2 with supplemental iron.	Baseline, Cycle 4 (7-day cycle)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax)	Cmax is the maximum serum concentration after a single IV dose of the study drug.	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
PK: Area Under the Curve (AUC[0-∞])

Eligibility Module

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)

Name	Affiliation	Role
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	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
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	92093

PubMed Identifier	Type	Citation	Retractions
28327200	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	Part A 0.3 Milligram Per Kilogram (mg/kg) LY2787106	Part A: Participants received 0.3 mg/kg, LY2787106 intravenously (IV), day 1 of up to three 21-day cycles.
FG001	Part A 1.0 mg/kg LY2787106	Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
FG002	Part A 3.0 mg/kg LY2787106	Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
FG003	Part A 10.0 mg/kg LY2787106	Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
FG004	Part B 10.0 mg/kg LY2787106	Part B: Participants received 10.0 mg/kg LY2787106, IV, on day 1 of up to eight 7-day cycles.
FG005	Part B 10.0 mg/kg LY2787106+Iron	Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Part A 0.3 mg/kg LY2787106	Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
BG001	Part A 1.0 mg/kg LY2787106	Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Clinically Significant Events

Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

All participants who received at least 1 dose of study drug.

Posted

Number

participants

Baseline to Study Completion (up to 5 Years)

ID	Title	Description
OG000	Part A 0.3 mg/kg LY2787106	Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
OG001	Part A 1.0 mg/kg LY2787106	Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A 0.3 mg/kg LY2787106	Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases