NCT01340976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

October 3, 2018

Completed
Last Updated

October 3, 2018

Status Verified

February 1, 2018

Enrollment Period

4.9 years

First QC Date

January 28, 2011

Results QC Date

February 17, 2018

Last Update Submit

February 17, 2018

Conditions

Anemia

Keywords

Cancer Related Anemia

Outcome Measures

Primary Outcomes (2)

  • 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 (5)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax)

    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-∞])

    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

  • Recommended Dose for Future Studies: Maximum Tolerated Dose (MTD)

    Baseline to Cycle 1 of Part A

  • Change From Baseline in Serum Iron

    Baseline, Cycle 4 (7-day cycle)

  • Mean Change From Baseline in Reticulocyte Count

    Baseline, Cycle 4 (7-day cycle)

Study Arms (3)

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: LY2787106Dietary Supplement: Iron Supplementation

Interventions

LY2787106DRUG

Administered IV.

10 mg/kg LY278710610 mg/kg LY2787106+IronLY2787106 Dose Escalation
Iron SupplementationDIETARY_SUPPLEMENT

Administered orally.

10 mg/kg LY2787106+Iron

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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, United States

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.

Santa Monica, California, 90404, United States

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.

Indianapolis, Indiana, 46202, United States

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.

Philadelphia, Pennsylvania, 19106, United States

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.

Dallas, Texas, 75246, United States

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.

Houston, Texas, 77030, United States

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.

The Woodlands, Texas, 77380, United States

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.

Seattle, Washington, 98109, United States

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.

Vancouver, Washington, 98684, United States

Location

Related Publications (1)

  • 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.

    PMID: 28327200DERIVED

MeSH Terms

Conditions

Anemia

Interventions

LY2787106

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

April 25, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 3, 2018

Results First Posted

October 3, 2018

Record last verified: 2018-02

Locations

US(9)