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Lung Diseases

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LY3009120 50 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

LY3009120 100 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

LY3009120 200 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

LY3009120 400 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met

LY3009120 500 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met

LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met

LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

LY3009120 capsule

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

The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.

A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body

A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer

Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.

Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.

PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.

PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.

PK: area under the concentration versus time curve \[0-∞\] of LY3009120 after a single oral dose Cycle 1 Day1.

PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state \[AUC0-τ\].

PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC\[0-τ\].

Eli Lilly and Company

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

50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Cohort 1

100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Cohort 2

200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Cohort 3

400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Cohort 4

500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Cohort 5

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Cohort 6

Cohort A

Cohort B

Cohort C

50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Dose Escalation Phase

100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Dose Escalation Phase

200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Dose Escalation Phase

400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Dose Escalation Phase

500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Dose Escalation Phase

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Dose Escalation Phase

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Dose Confirmation Phase

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

France

Australia

Spain

Region of Enrollment

This trial was terminated early based on the lack of sufficient clinical efficacy observed.

Chief Medical Officer

Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle.

Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle.

Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle.

Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle.

Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle.

Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.

Part A LY3009120

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

Maximum Tolerated Dose (MTD) of LY3009120

Complete Repsonse

Partial Response

Stable Disease

Progressive Disease

Not Assessed

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle

All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.

Number of Participants With Tumor Response

50 mg LY3009120

100 mg LY3009120

200 mg LY3009120

300 mg LY3009120

400 mg LY3009120

500 mg LY3009120

All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1

All participants in Part A who received at least one dose of study drug and have evaluable PK data for Cycle 1, Day 15, per protocol.

Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15

500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle

All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1

All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 15, per protocol.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15

500 mg LY3009210 administered orally every 12 hours daily in a 28-day cycle.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Dose confirmation Phase

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body	NCT02014116	Neoplasms Neoplasm Metast... Melanoma Carcinoma, Non-... Colorectal Neop...	LY3009120 capsu...	18 Years -	Eli Lilly and Company
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body	NCT02014116	Neoplasms Neoplasm Metast... Melanoma Carcinoma, Non-... Colorectal Neop...	LY3009120 capsu...	18 Years -	Eli Lilly and Company

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