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LY2787106

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

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
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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.
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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
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Frequently asked questions about LY2787106

What is LY2787106 used for?

LY2787106 is an investigational small molecule being developed for the treatment of anemia. It is being studied in the context of cancer and anemia, with a Phase 1 clinical trial conducted in the United States. The drug is not yet approved and remains in clinical development.

What does LY2787106 target?

LY2787106 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential role in treating anemia, particularly in patients with cancer, though the exact mechanism of action is not publicly detailed.

Who makes LY2787106?

LY2787106 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research on this investigational drug for the treatment of anemia.

What phase is LY2787106 in?

LY2787106 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug is still investigational. It has not received FDA approval and is not yet available as a marketed therapy for anemia.

What clinical trials is LY2787106 in?

LY2787106 has been studied in one clinical trial, identified as NCT01340976, titled 'A Phase 1 Study of LY2787106 in Cancer and Anemia.' This trial was completed in the United States and enrolled 33 participants aged 18 years and older. The study was controlled but not randomized or double-blinded.

Is LY2787106 the same as any other drug?

LY2787106 is not known to be the same as any other drug, as no alternative names have been reported. It is a distinct investigational compound developed by Eli Lilly and Company for the potential treatment of anemia.