Part 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).

Taladegib

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The purpose of this study is to find a recommended dose level and schedule of dosing LY2940680 that can safely be taken by participants with advanced cancer. The study will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells, and tumor cells. Finally, the study will help document any antitumor activity this drug may have.

Participants may include those who have previously received treatment with another hedgehog smoothened (Hh/Smo) inhibitor (excluding LY2940680).

A Study in Advanced Cancer

A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer

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.

Pharmacokinetics (PK): 1.Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC\[0-∞\])

PK: Maximum Observed Drug Concentration (Cmax)

PK: Area Under the Plasma Concentration-time Curve from time Zero to 24 Hours (AUC\[0-24\]) of LSN3185556

PK: Maximum Observed Drug Concentration (Cmax) of LSN3185556

Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions.

For each participant in Part C and D who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, PFS was censored at the date of last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Eli Lilly and Company

All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly

Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 1

Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 2

Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 3

Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 4

Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 5

Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.

Part C

Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).

Part D

Part A Cohort 2 : 100 mg taladegib administered orally QD on a 28-day cycle.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All participants who received at least one dose of study drug.

Part B of the study was not implemented as the estimated half-life was considered long enough for QD dosing.

Chief Medical Officer

Part A: Cohort 1 Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 2 Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 3 Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 4 Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 5 Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.

All Part A Participants

Part A participants who received at least one dose of study drug.

Recommended Phase 2 Dose: Maximum Tolerated Dose

Cycle 1, Day 1

Cycle 1, Day 15

50 milligram (mg) taladegib administered orally QD on a 28-day cycle.

50 mg Taladegib

100 mg taladegib administered orally QD on a 28-day cycle.

100 mg Taladegib

200 mg taladegib administered orally QD on a 28-day cycle.

200 mg Taladegib

400 mg taladegib administered orally QD on a 28-day cycle.

400 mg Taladegib

600 mg taladegib administered orally QD on a 28-day cycle.

600 mg Taladegib

All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])

Cycle 1,Day 15

PK: Time of Maximal Concentration (Tmax)

PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of LSN3185556

PK: Time of Maximal Concentration (Tmax) of LSN3185556

Number of Participants With Clinical Benefit Rate (Stable Disease [SD] + Partial Response [PR] + Complete Response [CR])

Part C and Part D participants who received at least one dose of study drug and had evaluable PFS data. Participants censored were Part C=8 and Part D=22. Per protocol, Part A data were not collected for PFS.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study in Advanced Cancer	NCT01226485	Advanced Cancer	Taladegib	18 Years -	Eli Lilly and Company
A Study in Advanced Cancer	NCT01226485	Advanced Cancer	Taladegib	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for taladegib

Every month we try and update this database with for taladegib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for taladegib

Every month we try and update this database with for taladegib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for taladegib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.