Trial · NCT02014116
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
NCT02014116, Phase 1, Terminated, Eli Lilly and Company; results first posted 2019-12-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body. Trials, record NCT02014116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02014116
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
- NCT number
- NCT02014116
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 51 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
- Interventions
- LY3009120 capsule
- First posted
- 2013-12-18
- Last updated
- 2019-12-27
- Results first posted
- 2019-12-27
- Limitations and caveats
- This trial was terminated early based on the lack of sufficient clinical efficacy observed.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of LY3009120 | 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. |
| Secondary | Number of Participants With Tumor Response | Baseline through progressive disease (Up to 7.36 months) | 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. |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose | PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1. |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 | Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15. |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 | Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28. |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: area under the concentration versus time curve \[0-∞\] of LY3009120 after a single oral dose Cycle 1 Day1. |
| Secondary | 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 | Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state \[AUC0-τ\]. |
| Secondary | 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 | Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC\[0-τ\]. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of LY3009120 | Cycle 1 (28 Days) | All participants in Part A who received at least one dose of study drug. | milligrams (mg) | NUMBER |
| SECONDARY | Number of Participants With Tumor Response | Baseline through progressive disease (Up to 7.36 months) | All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment. | participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose | 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. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 | Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | 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. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 | Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | 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. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | 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. | nanogram times hour/milliliter(ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | 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 | Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | 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. | nanogram*hour/milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | 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 | Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | 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. | ng*hr/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of LY3009120 | Part A LY3009120 | 300 | milligrams (mg) | ||
| Number of Participants With Tumor Response | Cohort A | Complete Repsonse | 0 | participants | |
| Number of Participants With Tumor Response | Cohort B | Complete Repsonse | 0 | participants | |
| Number of Participants With Tumor Response | Cohort C | Complete Repsonse | 0 | participants | |
| Number of Participants With Tumor Response | Cohort A | Partial Response | 0 | participants | |
| Number of Participants With Tumor Response | Cohort B | Partial Response | 0 | participants | |
| Number of Participants With Tumor Response | Cohort C | Partial Response | 0 | participants | |
| Number of Participants With Tumor Response | Cohort A | Stable Disease | 0 | participants | |
| Number of Participants With Tumor Response | Cohort B | Stable Disease | 0 | participants | |
| Number of Participants With Tumor Response | Cohort C | Stable Disease | 5 | participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 3 | |
| Overall Study | STARTED | Cohort 2 | 4 | |
| Overall Study | STARTED | Cohort 3 | 3 | |
| Overall Study | STARTED | Cohort 4 | 7 | |
| Overall Study | STARTED | Cohort 5 | 2 | |
| Overall Study | STARTED | Cohort 6 | 16 | |
| Overall Study | STARTED | Cohort A | 1 | |
| Overall Study | STARTED | Cohort B | 5 | |
| Overall Study | STARTED | Cohort C | 10 | |
| Overall Study | Received at Least One Dose of Study Drug | Cohort 1 | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events2,196
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 | 2 | 4 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 4 | 2 | 7 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 5 | 1 | 2 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 6 | 4 | 16 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B | 2 | 5 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort C | 3 | 10 | 6 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Cohort 1 | 0 | 3 | 0 |
1 to 10 of 2,196Source ClinicalTrials.gov
See all 2,196 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 2 | 3 |
| Total, all-cause mortality | Cohort 2 | 2 | 4 |
| Total, all-cause mortality | Cohort 3 | 1 | 3 |
| Total, all-cause mortality | Cohort 4 | 5 | 7 |
| Total, all-cause mortality | Cohort 5 | 0 | 2 |
| Total, all-cause mortality | Cohort 6 | 4 | 16 |
| Total, all-cause mortality | Cohort A | 1 | 1 |
| Total, all-cause mortality | Cohort B | 4 | 5 |
| Total, all-cause mortality | Cohort C | 4 | 10 |
| Total, other adverse events | Cohort 1 | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02014116
GET https://conductscience.org/api/trials/v1/NCT02014116/results?page=2