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LY2780301

Phase 1

Metastases, Neoplasm | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jul 31, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

LY2780301 · 1 trial · 1 indication

Phase 1 1
NCT01115751A Study in Patients With Advanced or Metastatic CancerMetastases, Neoplasm
COMPLETED80 Analytics
PHASE1COMPLETED
A Study in Patients With Advanced or Metastatic Cancer
Metastases, NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

Recommended dose for Phase 2 Studies
Baseline to study completion

Secondary Endpoints

Clinically significant effects
Baseline to study completion
Pharmacokinetics, area under the concentration-time curve
Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2
Best overall response (CR+PR+SD)
Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY2780301EXPERIMENTALPart A: daily dosing Part B (if determined as needed by pharmacokinetic, pharmacodynamic, and safety data): twice daily dosing Part C: Dose and frequency as determined by Parts A and B of the study.

Interventions

NameTypeDescription
LY2780301DRUGAdministered orally, daily for two 28-day cycles. Starting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therap...

Countries:Spain
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Frequently asked questions about LY2780301

What is LY2780301 used for?

LY2780301 is an investigational small molecule being studied for the treatment of advanced or metastatic cancer, including metastases and neoplasms. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes LY2780301?

LY2780301 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.

What phase is LY2780301 in?

LY2780301 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.

What clinical trials is LY2780301 in?

LY2780301 has one completed clinical trial, NCT01115751, titled "A Study in Patients With Advanced or Metastatic Cancer." This Phase 1 study enrolled 80 participants in Spain and was not randomized or blinded.

How does LY2780301 work?

LY2780301 is a small molecule therapeutic being investigated for its anti-cancer activity in patients with advanced or metastatic cancer. Its specific molecular target has not been disclosed in available information.