NeoplasmsPhase 1NCT02014116

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

A Phase 1 study testing LY3009120 capsule in people with Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 6 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Neoplasm Metastasis, Melanoma
What is being tested?: LY3009120 capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 6 sitesin 4 countries
Study dates: 26 Nov 2013to 5 Oct 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 4 countries.

Country

City, postcode or hospital

6 sites in 4 countries

United States3 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258

Other trials in United States

Australia1 site

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, 6009

Other trials in Australia

France1 site

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.
Villejuif, 94805

Other trials in France

Spain1 site

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.
Barcelona, 08035

Other trials in Spain

About this study

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

Conditions: Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
Being tested: LY3009120 capsule
Medical subject headings: Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3009120 capsuleDrug
Administered orally.

Study groups in NCT02014116
Study group	Role	What they receive
Cohort 1 Dose Escalation	Experimental	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. Receives: Drug: LY3009120 capsule
Cohort 2 Dose Escalation	Experimental	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. Receives: Drug: LY3009120 capsule
Cohort 3 Dose Escalation	Experimental	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. Receives: Drug: LY3009120 capsule
Cohort 4 Dose Escalation	Experimental	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 Receives: Drug: LY3009120 capsule
Cohort 5 Dose Escalation	Experimental	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 Receives: Drug: LY3009120 capsule
Cohort 6 Dose Escalation	Experimental	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 Receives: Drug: LY3009120 capsule
Cohort A Dose Confirmation	Experimental	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. Receives: Drug: LY3009120 capsule
Cohort B Dose Confirmation	Experimental	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. Receives: Drug: LY3009120 capsule
Cohort C Dose Confirmation	Experimental	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. Receives: Drug: LY3009120 capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Cycle 1 (28 Days)

Secondary outcomes (7)

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.
Measured: Baseline through progressive disease (Up to 7.36 months)
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.
Measured: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
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.
Measured: Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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.
Measured: Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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.
Measured: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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].
Measured: Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
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].
Measured: Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 20135 Oct 2018

First posted18 Dec 2013 (estimated)
Study start26 Nov 2013
Primary completion7 Apr 2017
Study completion5 Oct 2018

Why it stopped: This trial was terminated early based on the lack of sufficient clinical efficacy observed.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02014116
Sponsor's protocol ID: 13873
Other IDs: I6X-MC-JBDA
Status last verified: Dec 2019
First submitted: 12 Dec 2013
Last updated: 27 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer
ClinicalTrials.gov ID: NCT02014116
Acronym / sponsor ID: 13873
Conditions: Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: This trial was terminated early based on the lack of sufficient clinical efficacy observed.
Enrolment: 51 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 26 Nov 2013 (actual)
Primary completion: 7 Apr 2017 (actual)
Study completion: 5 Oct 2018 (actual)
First posted: 18 Dec 2013 (estimated)
Results: Posted 27 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Cohort 1 Dose Escalation	Experimental	Drug: LY3009120 capsuleLY3009120 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.
Cohort 2 Dose Escalation	Experimental	Drug: LY3009120 capsuleLY3009120 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.
Cohort 3 Dose Escalation	Experimental	Drug: LY3009120 capsuleLY3009120 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.
Cohort 4 Dose Escalation	Experimental	Drug: LY3009120 capsuleLY3009120 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
Cohort 5 Dose Escalation	Experimental	Drug: LY3009120 capsuleLY3009120 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
Cohort 6 Dose Escalation	Experimental	Drug: LY3009120 capsuleLY3009120 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
Cohort A Dose Confirmation	Experimental	Drug: LY3009120 capsuleLY3009120 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.
Cohort B Dose Confirmation	Experimental	Drug: LY3009120 capsuleLY3009120 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.
Cohort C Dose Confirmation	Experimental	Drug: LY3009120 capsuleLY3009120 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3009120 capsuleAdministered orally.	Drug	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

Primary outcome

Maximum Tolerated Dose (MTD) of LY3009120
Time frame: Cycle 1 (28 Days)
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.

7 secondary outcomes

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

Results and safety

Results posted to the registry on 27 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	3	0
Cohort 2	4	0
Cohort 3	3	0
Cohort 4	7	0
Cohort 5	2	0
Cohort 6	16	0
Cohort A	1	0
Cohort B	5	0
Cohort C	10	0

Primary outcome: Maximum Tolerated Dose (MTD) of LY3009120

Time frame: Cycle 1 (28 Days). Number. Unit: milligrams (mg)

Measure	Part A LY3009120 n = 35
Value	300

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

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Study Completion (Up to 33 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Cohort 2	2 of 4 (50%)	4 of 4 (100%)	2 of 4
Cohort 3	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Cohort 4	5 of 7 (71.4%)	7 of 7 (100%)	5 of 7
Cohort 5	1 of 2 (50%)	2 of 2 (100%)	0 of 2
Cohort 6	12 of 16 (75%)	16 of 16 (100%)	4 of 16
Cohort A	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Cohort B	5 of 5 (100%)	5 of 5 (100%)	4 of 5
Cohort C	6 of 10 (60%)	9 of 10 (90%)	4 of 10

Limitations and caveats (from the sponsor): This trial was terminated early based on the lack of sufficient clinical efficacy observed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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 study director

Eli Lilly and Company

6 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3009120 capsule in people with Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 6 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of LY3009120 (time frame: Cycle 1 (28 Days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02014116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.