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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer
Secondary ID [1] 0 0
I6X-MC-JBDA
Secondary ID [2] 0 0
13873
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Neoplasm Metastasis 0 0
Melanoma 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) of LY3009120
Timepoint [1] 0 0
Cycle 1 (28 Days)
Secondary outcome [1] 0 0
Number of Participants With Tumor Response
Timepoint [1] 0 0
Baseline through progressive disease (Up to 7.36 months)
Secondary outcome [2] 0 0
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
Timepoint [2] 0 0
Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
Secondary outcome [3] 0 0
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
Timepoint [3] 0 0
Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Secondary outcome [4] 0 0
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
Timepoint [4] 0 0
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Secondary outcome [5] 0 0
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-8]) of LY3009120 Cycle 1 Day 1
Timepoint [5] 0 0
Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2018
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
France
State/province [4] 0 0
Villejuif
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02014116