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Taladegib

Phase 1

Advanced Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Sep 13, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

Taladegib · 1 trial · 1 indication

Phase 1 1
NCT01226485A Study in Advanced CancerAdvanced Cancer
COMPLETED84 Analytics
PHASE1COMPLETED
A Study in Advanced Cancer
Advanced CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about Taladegib

What is Taladegib used for?

Taladegib is an investigational small molecule being studied for the treatment of advanced cancer. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with advanced cancer who are at least 18 years old.

Who makes Taladegib?

Taladegib is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for advanced cancer.

What phase is Taladegib in?

Taladegib 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, and the drug is not currently in any active clinical trials.

What clinical trials is Taladegib in?

Taladegib has been studied in one clinical trial, identified as NCT01226485, titled "A Study in Advanced Cancer." This was a Phase 1, uncontrolled trial conducted in the United States with 84 participants. The trial has been completed.

Is Taladegib FDA approved?

Taladegib is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced cancer. The completed Phase 1 trial, NCT01226485, evaluated the drug in 84 patients, but no approval has been granted.