Recent Updates
Recently added Catalysts

LY2787106

Phase 1

Anemia | Small molecule | Hematology |Eli Lilly and Company|Trials Updated: Oct 3, 2018

LY2787106 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2011

LY2787106 target and mechanism

Molecular targetHAMP
Target classInhibitor
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

LY2787106 clinical trials

LY2787106 · 1 trial · 1 indication

Phase 1 1
NCT01340976A Phase 1 Study of LY2787106 in Cancer and AnemiaAnemia
COMPLETED33 Analytics
PHASE1COMPLETED
A Phase 1 Study of LY2787106 in Cancer and Anemia
AnemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Clinically Significant Events
Baseline to Study Completion (up to 5 Years)

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.

Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation
Baseline, Cycle 4 (7-day cycle)

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.

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
LY2787106 Dose EscalationEXPERIMENTALPart A: Dose escalation starting at 0.3 milligram/kilogram (mg/kg), intravenously (IV), day one of up to three 21-day cycles.
10 mg/kg LY2787106EXPERIMENTALPart 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.
10 mg/kg LY2787106+IronEXPERIMENTALPart 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.

Interventions

NameTypeDescription
LY2787106DRUGAdministered IV.
Iron SupplementationDIETARY_SUPPLEMENTAdministered orally.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 hemoglo...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about LY2787106

What is LY2787106 used for?

LY2787106 is an investigational small molecule being studied for the treatment of anemia, including anemia in patients with cancer. It has been evaluated in a Phase 1 clinical trial and is not approved for any indication. Eli Lilly and Company is the developer.

What does LY2787106 target?

LY2787106 targets HAMP, also known as hepcidin. It is an inhibitor of this target. By inhibiting hepcidin, the drug is designed to affect iron regulation, which is relevant to anemia. The target class is an inhibitor, and the molecule is a small molecule.

Who makes LY2787106?

LY2787106 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is responsible for the clinical development of this investigational anemia therapy.

What phase is LY2787106 in?

LY2787106 is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is LY2787106 in?

LY2787106 has been studied in one completed Phase 1 trial, NCT01340976, titled A Phase 1 Study of LY2787106 in Cancer and Anemia. The trial enrolled 33 participants in the United States and included adults 18 years and older.