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Drug: LY573636-

Phase 1

Metastatic Renal Cell Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jan 10, 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 Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01258348A Phase 1b Trial in Patients With Renal Cell CancerPHASE1 COMPLETED 21Jul 1, 2008Feb 1, 2012Jan 10, 20195 United States, Canada
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Study Endpoints
Primary Endpoints
Recommended Dose for Phase 2 Studies of LY573636-Sodium Combined With Sunitinib in Participants With Metastatic Renal Cell Carcinoma
Predose up to 42 days postdose in Cycle 1 (6 weeks per cycle)

Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia with bleeding; Gr ≥3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments; Gr ≥3 elevated hepatic enzyme abnormalities in the setting of preexisting hepatic metastasis may not be considered a DLT; a DLT can be declared if a participant experiences increasing toxicity during treatment.

Secondary Endpoints
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Predose up to 2 hours postdose in Cycles 1 and 2 (6 weeks per cycle)
Number of Participants With Tumor Responses
Baseline to end of treatment up to 66 weeks
Sunitinib Pharmacokinetics in the Presence of LY573636: Area Under the Curve (AUC)
Days 1 to 42 in Cycle 1 (6 weeks per cycle)
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Study Design & Arms
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY573636 +sunitinibEXPERIMENTAL -
Interventions
NameTypeDescription
Drug: LY573636-sodiumDRUGParticipant specific dose based on height, weight and gender to target a specific exposure range, administered intravenously on Day 4 of a 42-day (6-week) cycle. Dose will be escalated to reach the maximum tolerated dose (MTD). A cohort of participants enrolled after MTD will receive albumin-tailored doses. Participants may continue on treatment until clinical or objective disease progression.
SunitinibDRUG37.5 or 50 milligrams (mg), administered orally, daily for a 42-day (6-week) cycle. Participants may continue on treatment until clinical or objective disease progression.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Participants must have a histologically confirmed diagnosis of metastatic Renal Cell Carcinoma (RCC) * Participants must have received no prior treatment with a cytotoxic-based chemotherapy regimen * Participants must have measurable disease as defined by the Response Evaluati...

Countries:United StatesCanada
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