NCT02014116 is a Phase 1 clinical trial of LY3009120 capsule in Neoplasms, sponsored by Eli Lilly and Company.

Who is sponsoring NCT02014116?

NCT02014116 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT02014116?

Interventions in NCT02014116: LY3009120 capsule.

What condition does NCT02014116 study?

NCT02014116 studies Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms.

Is NCT02014116 still recruiting?

NCT02014116 is currently terminated. Last updated 27 December 2019.

Are results published for NCT02014116?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-12-27 · How we verify

NCT02014116

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Results posted Last updated 27 December 2019

What this trial tests

Phase 1 trial testing LY3009120 capsule in Neoplasms in 51 participants. Terminated before completion.

Timeline

26 November 2013

Primary endpoint
7 April 2017

5 October 2018

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	26 November 2013
Primary completion	7 April 2017
Estimated completion	5 October 2018
Sites	6 locations across France, United States, Australia, Spain

Drugs / interventions tested

LY3009120 capsule — full drug profile →

Conditions studied

Neoplasms — all drugs for Neoplasms →
Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
Melanoma — all drugs for Melanoma →
Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Neoplasms or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Tolerated Dose (MTD) of LY3009120 Primary · 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

Group	Value	95% CI
Part A LY3009120	300

Number of Participants With Tumor Response Secondary · 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.

Complete Repsonse

Group	Value	95% CI
Cohort A	0
Cohort B	0
Cohort C	0

Partial Response

Group	Value	95% CI
Cohort A	0
Cohort B	0
Cohort C	0

Stable Disease

Group	Value	95% CI
Cohort A	0
Cohort B	0
Cohort C	5

Progressive Disease

Group	Value	95% CI
Cohort A	1
Cohort B	4
Cohort C	1

Not Assessed

Group	Value	95% CI
Cohort A	0
Cohort B	1
Cohort C	4

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 Secondary · 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.

Group	Value	95% CI
50 mg LY3009120	105.29	± 228.24
100 mg LY3009120	436	± 96
200 mg LY3009120	675	± 81
300 mg LY3009120	976	± 72
400 mg LY3009120	688	± 46
500 mg LY3009120	1717.76	± 1464.86

Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 Secondary · 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.

Group	Value	95% CI
50 mg LY3009120	420.3	± 241.2
100 mg LY3009120	515	± 75
200 mg LY3009120	704.74	± 1267.39
300 mg LY3009120	1430	± 66
400 mg LY3009120	775	± 19

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 Secondary · 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.

Group	Value	95% CI
50 mg LY3009120	587.75	± 206.15
100 mg LY3009120	550	± 113
200 mg LY3009120	594	± 32
300 mg LY3009120	1150	± 69
400 mg LY3009120	670	± 30

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 Secondary · 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.

Group	Value	95% CI
50 mg LY3009120	960	± 1540
100 mg LY3009120	2360	± 56
200 mg LY3009120	4640	± 28
300 mg LY3009120	7560	± 47
400 mg LY3009120	5910	± 23
500 mg LY3009120	16,400	± 14,700

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 Secondary · 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 \[AUC0-τ\].

Group	Value	95% CI
50 mg LY3009120	2240	± 1310
100 mg LY3009120	3520	± 7920
200 mg LY3009120	5140	± 6260
300 mg LY3009120	8460	± 60
400 mg LY3009120	5440	± 17

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 Secondary · 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\[0-τ\].

Group	Value	95% CI
50 mg LY3009120	3120	± 1300
100 mg LY3009120	3100	± 102
200 mg LY3009120	5200	± 7
300 mg LY3009120	6580	± 47
400 mg LY3009120	4640	± 18

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to Study Completion (Up to 33 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1

Serious: 0/3 (0%)

Deaths: 2/3

Cohort 2

Serious: 2/4 (50%)

Deaths: 2/4

Cohort 3

Serious: 1/3 (33%)

Deaths: 1/3

Cohort 4

Serious: 5/7 (71%)

Deaths: 5/7

Cohort 5

Serious: 1/2 (50%)

Deaths: 0/2

Cohort 6

Serious: 12/16 (75%)

Deaths: 4/16

Cohort A

Serious: 1/1 (100%)

Deaths: 1/1

Cohort B

Serious: 5/5 (100%)

Deaths: 4/5

Cohort C

Serious: 6/10 (60%)

Deaths: 4/10

Serious adverse events (41 terms)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6	Cohort A	Cohort B	Cohort C
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Intestinal perforation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Large intestine perforation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—	—	—	—	—
Hyperthermia	General disorders	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—
Erysipelas	Infections and infestations	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Pain in jaw	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—

Other adverse events (203 terms — click to expand)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6	Cohort A	Cohort B	Cohort C
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oedema	General disorders	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Dermatitis acneiform	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pyrexia, Pleural effusion, Angina pectoris, Cardiac arrest, Abdominal pain, Diarrhoea, Intestinal perforation, Large intestine perforation.

Data from ClinicalTrials.gov NCT02014116 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Role of oncogenic KRAS in the prognosis, diagnosis and treatment of colorectal cancer.
Zhu G, Pei L, Xia H, Tang Q, et al · · 2021 · cited 342× · PMID 34742312 · DOI 10.1186/s12943-021-01441-4
New perspectives for targeting RAF kinase in human cancer.
Karoulia Z, Gavathiotis E, Poulikakos PI. · · 2017 · cited 332× · PMID 28984291 · DOI 10.1038/nrc.2017.79
Targeting the ERK Signaling Pathway in Melanoma.
Savoia P, Fava P, Casoni F, Cremona O. · · 2019 · cited 137× · PMID 30934534 · DOI 10.3390/ijms20061483
Low-Dose Vertical Inhibition of the RAF-MEK-ERK Cascade Causes Apoptotic Death of KRAS Mutant Cancers.
Ozkan-Dagliyan I, Diehl JN, George SD, Schaefer A, et al · · 2020 · cited 84× · PMID 32553168 · DOI 10.1016/j.celrep.2020.107764
Receptor tyrosine kinases and downstream pathways as druggable targets for cancer treatment: the current arsenal of inhibitors.
Montor WR, Salas AROSE, Melo FHM. · · 2018 · cited 80× · PMID 29455659 · DOI 10.1186/s12943-018-0792-2
A Phase I Study of LY3009120, a Pan-RAF Inhibitor, in Patients with Advanced or Metastatic Cancer.
Sullivan RJ, Hollebecque A, Flaherty KT, Shapiro GI, et al · · 2020 · cited 74× · PMID 31645440 · DOI 10.1158/1535-7163.mct-19-0681
Treatment of <i>NRAS</i>-mutated advanced or metastatic melanoma: rationale, current trials and evidence to date.
Boespflug A, Caramel J, Dalle S, Thomas L. · · 2017 · cited 44× · PMID 28717400 · DOI 10.1177/1758834017708160
Targeting mutant NRAS signaling pathways in melanoma.
Vu HL, Aplin AE. · · 2016 · cited 42× · PMID 26987942 · DOI 10.1016/j.phrs.2016.03.007

Verify or expand the search:

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Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02014116 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 27 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02014116.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing