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LY573636-

Phase 2

Sarcoma, Soft Tissue | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Sep 18, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment101
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00490451A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue SarcomaPHASE2 COMPLETED 101Aug 1, 2007Feb 1, 2010Sep 18, 201913 United States, Argentina +1
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Study Endpoints
Primary Endpoints
Progression-Free Survival
First treatment dose to measured progressive disease or death from any cause up to 15.57 months

Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Secondary Endpoints
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)
First treatment dose to measured progressive disease or death due to any cause up to 15.57 months
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)
First treatment dose to measured progressive disease or death due to any cause up to 15.57 months
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY573636EXPERIMENTAL -
Interventions
NameTypeDescription
LY573636-sodiumDRUGLY573636 dose is dependent on patient's height, weight, and gender to target a specific maximum concentration (Cmax). LY573636 is administered intravenously every 21 or 28 days until disease progression or other criteria for patient discontinuation are met.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Diagnosis of soft tissue sarcoma that is unresectable or metastatic * Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin). * Must have stopped all previous treatme...

Countries:United StatesArgentinaSpain
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