Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Sep 2010

Longer than P75 for phase_1

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.1 years study duration

Study Start

First participant enrolled

September 1, 2010

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed

2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed

2 years until next milestone

Results Posted

Study results publicly available

September 13, 2019

Completed

Last Updated

September 13, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

October 20, 2010

Results QC Date

May 8, 2019

Last Update Submit

August 7, 2019

Conditions

Advanced Cancer

Keywords

CancerTerminalSolid TumorEnd StageMetastatic

Outcome Measures

Primary Outcomes (1)

Recommended Phase 2 Dose: Maximum Tolerated Dose
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.
Time to First Dose to the End of Cycle 1 of Part A (Up To 28 Days)

Secondary Outcomes (8)

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
PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of LSN3185556
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) of LSN3185556
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
+3 more secondary outcomes

Study Arms (1)

Taladegib

EXPERIMENTAL

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).

Drug: Taladegib

Interventions

TaladegibDRUG

Administered IV

Also known as: LY2940680

Taladegib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 adequate organ function, including:
Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 5 days after the erythrocyte transfusion.
Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the liver has tumor involvement AST and ALT equaling less than or equal to 5 times ULN are acceptable.
Renal: Serum creatinine less than or equal to 1.5 times ULN.
Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued previous treatments for cancer and recovered from the acute effects of therapy (for example, at least 42 days for mitomycin-C or nitrosoureas, 28 days for other chemotherapy and biologics. At the discretion of the investigator, hormone refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy and breast cancer patients who are stable on antiestrogen therapy (for example, an aromatase inhibitor) may continue treatment

You may not qualify if:

Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
Have serious preexisting medical conditions
Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
Have known current hematologic malignancies or acute or chronic leukemia
Have a known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis (screening is not required)
Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
Have QTc interval of \>500 msec on screening electrocardiogram
Patients who have previously received treatment with LY2940680

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (12)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Scottsdale, Arizona, 85260, United States

Location

Redwood City, California, 94063, United States

Location

Aurora, Colorado, 80045, United States

Location

Fort Myers, Florida, 33908, United States

Location

Tampa, Florida, 33612, United States

Location

Las Vegas, Nevada, 89169, United States

Location

New York, New York, 10065, United States

Location

Oklahoma City, Oklahoma, 73104, United States

Location

Nashville, Tennessee, 37203, United States

Location

Fort Worth, Texas, 76177, United States

Location

Houston, Texas, 77030, United States

Location

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

LY2940680

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2015

Study Completion

October 1, 2017

Last Updated

September 13, 2019

Results First Posted

September 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing: Will not share

Locations

US(12)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

Taladegib

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations