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

Primary Purpose

Neoplasms, Neoplasm Metastasis, Melanoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3009120 capsule
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Advanced or metastatic cancer
  • Other available therapies have failed to cure the cancer
  • The cancer that has no proven effective therapy
  • The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
  • Able to swallow capsules

Exclusion Criteria:

  • Have active cancer in the brain or spinal cord
  • Have an active infection of any kind (fungal, viral, or bacterial)
  • Have a cancer of the blood
  • Are pregnant or breastfeeding
  • Have some types of eye problems or impairments

Sites / Locations

  • Pinnacle Oncology Hematology
  • Massachusetts General Hospital
  • University of Texas MD Anderson Cancer Center
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 Dose Escalation

Cohort 2 Dose Escalation

Cohort 3 Dose Escalation

Cohort 4 Dose Escalation

Cohort 5 Dose Escalation

Cohort 6 Dose Escalation

Cohort A Dose Confirmation

Cohort B Dose Confirmation

Cohort C Dose Confirmation

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of LY3009120
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.

Secondary Outcome Measures

Number of Participants With Tumor Response
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.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, 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
PK: area under the concentration versus time curve [0-∞] of LY3009120 after a single oral dose Cycle 1 Day1.
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
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].
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
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].

Full Information

First Posted
December 12, 2013
Last Updated
December 20, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02014116
Brief Title
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
Official Title
A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
This trial was terminated early based on the lack of sufficient clinical efficacy observed.
Study Start Date
November 26, 2013 (Actual)
Primary Completion Date
April 7, 2017 (Actual)
Study Completion Date
October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2 Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3 Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 4 Dose Escalation
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 5 Dose Escalation
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 6 Dose Escalation
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort A Dose Confirmation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B Dose Confirmation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort C Dose Confirmation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LY3009120 capsule
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) of LY3009120
Description
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.
Time Frame
Cycle 1 (28 Days)
Secondary Outcome Measure Information:
Title
Number of Participants With Tumor Response
Description
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.
Time Frame
Baseline through progressive disease (Up to 7.36 months)
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
Description
PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
Time Frame
Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
Description
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
Time Frame
Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
Description
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
Time Frame
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1
Description
PK: area under the concentration versus time curve [0-∞] of LY3009120 after a single oral dose Cycle 1 Day1.
Time Frame
Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Title
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
Description
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].
Time Frame
Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Title
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
Description
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].
Time Frame
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced or metastatic cancer Other available therapies have failed to cure the cancer The cancer that has no proven effective therapy The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) Able to swallow capsules Exclusion Criteria: Have active cancer in the brain or spinal cord Have an active infection of any kind (fungal, viral, or bacterial) Have a cancer of the blood Are pregnant or breastfeeding Have some types of eye problems or impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Oncology Hematology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
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.
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
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.
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
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.
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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