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Taladegib

Phase 1

Advanced Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Sep 13, 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 Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01226485A Study in Advanced CancerPHASE1 COMPLETED 84Sep 1, 2010Oct 1, 2017Sep 13, 201912 United States
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Study Endpoints
Primary Endpoints
Recommended Phase 2 Dose: Maximum Tolerated Dose
Time to First Dose to the End of Cycle 1 of Part A (Up To 28 Days)

Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest tested dose that had \<33% probability of causing a DLT in Cycle 1 of Part A.

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h
PK: Maximum Observed Drug Concentration (Cmax)
Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h
PK: Time of Maximal Concentration (Tmax)
Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TaladegibEXPERIMENTALPart A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle. Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).
Interventions
NameTypeDescription
TaladegibDRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy. * Have the presence of measurable or nonmeasurable disease * Have...

Countries:United States
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