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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02014116
Registration number
NCT02014116
Ethics application status
Date submitted
12/12/2013
Date registered
18/12/2013
Date last updated
27/12/2019
Titles & IDs
Public title
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
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Scientific title
A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer
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Secondary ID [1]
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I6X-MC-JBDA
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Secondary ID [2]
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13873
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms
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Neoplasm Metastasis
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Melanoma
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Carcinoma, Non-Small-Cell Lung
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Colorectal Neoplasms
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY3009120 capsule
Experimental: Cohort 1 Dose Escalation - 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.
Experimental: Cohort 2 Dose Escalation - 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.
Experimental: Cohort 3 Dose Escalation - 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.
Experimental: Cohort 4 Dose Escalation - 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
Experimental: Cohort 5 Dose Escalation - 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
Experimental: Cohort 6 Dose Escalation - 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
Experimental: Cohort A Dose Confirmation - 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.
Experimental: Cohort B Dose Confirmation - 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.
Experimental: Cohort C Dose Confirmation - 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.
Treatment: Drugs: LY3009120 capsule
Administered orally.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maximum Tolerated Dose (MTD) of LY3009120
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Assessment method [1]
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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.
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Timepoint [1]
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Cycle 1 (28 Days)
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Secondary outcome [1]
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Number of Participants With Tumor Response
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline through progressive disease (Up to 7.36 months)
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Secondary outcome [2]
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Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
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Assessment method [2]
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PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
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Timepoint [2]
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Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
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Secondary outcome [3]
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Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
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Assessment method [3]
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PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
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Timepoint [3]
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Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Secondary outcome [4]
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Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
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Assessment method [4]
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PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
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Timepoint [4]
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Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Secondary outcome [5]
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-8]) of LY3009120 Cycle 1 Day 1
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Assessment method [5]
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PK: area under the concentration versus time curve [0-8] of LY3009120 after a single oral dose Cycle 1 Day1.
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Timepoint [5]
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Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Secondary outcome [6]
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-t]) of LY3009120 Cycle 1 Day 15
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Assessment method [6]
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PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state [AUC0-t].
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Timepoint [6]
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Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Secondary outcome [7]
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-t]) of LY3009120 Cycle 1 Day 28
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Assessment method [7]
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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-t].
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Timepoint [7]
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Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/10/2018
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Sample size
Target
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Accrual to date
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Final
51
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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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. - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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France
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State/province [4]
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Villejuif
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Country [5]
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Spain
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State/province [5]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02014116
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02014116
Download to PDF