NCT01719380 is a Phase 2 clinical trial of LGX818 in Colorectal Cancer, sponsored by Pfizer.

Who is sponsoring NCT01719380?

NCT01719380 is sponsored by Pfizer.

What drugs are being tested in NCT01719380?

Interventions in NCT01719380: LGX818, Cetuximab, BYL719.

What condition does NCT01719380 study?

NCT01719380 studies Colorectal Cancer.

Is NCT01719380 still recruiting?

NCT01719380 is currently completed. Last updated 23 June 2021.

Are results published for NCT01719380?

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

Last reviewed 2021-06-23 · How we verify

NCT01719380

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

Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

Completed Phase 2 Results posted Last updated 23 June 2021

What this trial tests

Phase 2 trial testing LGX818 in Colorectal Cancer in 156 participants. Completed in 12 February 2019.

Timeline

23 November 2012

Primary endpoint
31 October 2015

12 February 2019

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	156
Start date	23 November 2012
Primary completion	31 October 2015
Estimated completion	12 February 2019
Sites	52 locations across France, Italy, Japan, Netherlands, Belgium, Germany, Norway, South Korea

Drugs / interventions tested

LGX818 (lgx818) — full drug profile →
Cetuximab (cetuximab) — full drug profile →
BYL719 — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer. 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.

Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1 Primary · Cycle 1: Day 1 to Day 28

DLTs were defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment and meets any of the criteria included blood and lymphatic system disorders, investigations (blood, renal, hepatic, metabolic), skin and subcutaneous tissue disorders: rash, HFSR (hand foot skin reaction) and/or photosensitivity, metabolism and nutrition disorders: hyperglycemia, gastrointestinal disorders, cardiac disorders, vascular disorders, general disorders and a

Group	Value	95% CI
Phase 1b: LGX818 100 mg + Cetuximab	0
Phase 1b: LGX818 200 mg + Cetuximab	1
Phase 1b: LGX818 400 mg + Cetuximab	1
Phase 1b: LGX818 450 mg + Cetuximab	1
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	0
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	0
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	1
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	1

Phase 2: Progression Free Survival (PFS) Primary · From the date of randomization until the first documentation of disease progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)

PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. Participants who did not progress per RECIST (Response Evaluation Criteria in Solid Tumors) version (v) 1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.

Group	Value	95% CI
Phase 2: LGX818 200 mg + Cetuximab	4.2	3.0 – 5.1
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	4.9	4.0 – 7.1

Number of Participants With Treatment - Emergent Adverse Events of Grade 3 or 4 Severity Based on National Cancer Institute of Common Terminology Criteria (NCI-CTCAE), Version 4.0 Secondary · From screening up to 30 days after the last dose of study treatment (for a maximum duration of 43 months, approximately)

An AE was any untoward medical occurrence attributed to study drug in participants who received study drug. As per NCI-CTCAE v4.0, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening conse

Group	Value	95% CI
Phase 1b: LGX818 100 mg + Cetuximab	2
Phase 1b: LGX818 200 mg + Cetuximab	4
Phase 1b: LGX818 400 mg + Cetuximab	6
Phase 1b: LGX818 450 mg + Cetuximab	7
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	3
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	5
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	7
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	6
Phase 2: LGX818 200 mg + Cetuximab	33
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	43

Apparent Total Plasma Clearance (CL/F) of LGX818 (Encorafenib) Secondary · Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Group	Value	95% CI
Phase 1b: LGX818 100 mg + Cetuximab	16.8	± 3.60
Phase 1b: LGX818 200 mg + Cetuximab	11.7	± 6.10
Phase 1b: LGX818 400 mg + Cetuximab	12.1	± 5.95
Phase 1b: LGX818 450 mg + Cetuximab	12.3	± 4.96
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	7.69	± 3.13
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	14.2	± 5.75
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	14.1	± 3.65
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	17.8	± 17.4
Phase 2: LGX818 200 mg + Cetuximab	13.1	± 5.07
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	10.9	± 5.70

Apparent Total Plasma Clearance at Steady State (CL/F, ss) of LGX818 (Encorafenib) Secondary · Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Cycle 1 Day 8

Group	Value	95% CI
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	17.0	± 3.42
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	24.4	± 18.3
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	15.4	± 4.25
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	22.4	± 17.7

Cycle 2 Day 1

Group	Value	95% CI
Phase 1b: LGX818 100 mg + Cetuximab	13.9	± 4.72
Phase 1b: LGX818 200 mg + Cetuximab	31.1	± 11.9
Phase 1b: LGX818 400 mg + Cetuximab	31.6	± 2.19
Phase 1b: LGX818 450 mg + Cetuximab	30.5	± 12.3
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	32.6	± 6.88
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	20.2	± 7.91
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	22.7	± 5.68
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	38.4	± 16.4
Phase 2: LGX818 200 mg + Cetuximab	28.2	± 8.97
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	23.3	± 11.6

Apparent Total Plasma Clearance (CL/F) of BYL719 (Alpelisib) Secondary · Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Group	Value	95% CI
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	12.7	± 2.03
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	12.1	± 3.96
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	11.6	± 1.85
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	11.7	± 5.38
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	15.6	± 9.61

Apparent Total Plasma Clearance at Steady State (CL/F, ss) of BYL719 (Alpelisib) Secondary · Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Cycle 1 Day 8

Group	Value	95% CI
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	16.5	± 5.96
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	13.2	± 2.29
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	13.7	± 7.20
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	11.6	± 6.05

Cycle 2 Day 1

Group	Value	95% CI
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	18.3	± 0.794
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	10.3	± 1.23
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	12.5	± 1.60
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	19.0	± 6.51
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	17.9	± 10.5

Apparent Terminal Volume of Distribution (Vz/F) of LGX818 (Encorafenib) Secondary · Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Group	Value	95% CI
Phase 1b: LGX818 100 mg + Cetuximab	104	± 28.3
Phase 1b: LGX818 200 mg + Cetuximab	60.3	± 25.8
Phase 1b: LGX818 400 mg + Cetuximab	62.8	± 31.8
Phase 1b: LGX818 450 mg + Cetuximab	57.2	± 29.6
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	49.2	± 12.4
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	75.7	± 31.6
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	64.6	± 20.6
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	60.7	± 44.0
Phase 2: LGX818 200 mg + Cetuximab	63.5	± 29.9
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	80.9	± 93.9

Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of LGX818 (Encorafenib) Secondary · Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Volume of distribution at steady state is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.

Cycle 1 Day 8

Group	Value	95% CI
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	78.4	± 13.0
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	98.2	± 84.5
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	78.6	± 26.2
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	88.8	± 53.6

Cycle 2 Day 1

Group	Value	95% CI
Phase 1b: LGX818 100 mg + Cetuximab	66.8	± 13.7
Phase 1b: LGX818 200 mg + Cetuximab	131	± 45.8
Phase 1b: LGX818 400 mg + Cetuximab	110	± 41.1
Phase 1b: LGX818 450 mg + Cetuximab	142	± 84.5
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	137	± 32.9
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	91.6	± 41.4
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	102	± 39.9
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	187	± 89.5
Phase 2: LGX818 200 mg + Cetuximab	117	± 37.6
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	105	± 42.2

Apparent Terminal Volume of Distribution (Vz/F) of BYL719 (Alpelisib) Secondary · Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Group	Value	95% CI
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	112	± 22.0
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	104	± 31.0
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	105	± 34.3
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	106	± 78.6
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	123	± 50.7

Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of BYL719 (Alpelisib) Secondary · Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.

Cycle 1 Day 8

Group	Value	95% CI
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	110	± 40.7
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	97.0	± 20.6
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	105	± 30.2
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	82.5	± 18.8

Cycle 2 Day 1

Group	Value	95% CI
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	138	± 20.7
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	75.4	± 11.2
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	104	± 10.7
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	144	± 44.5
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	149	± 100

Time to Reach Maximum Observed Plasma Concentration (Tmax) of LGX818 (Encorafenib) Secondary · Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose

Tmax was defined as the time to reach maximum observed plasma concentration of encorafenib.

Group	Value	95% CI
Phase 1b: LGX818 100 mg + Cetuximab	2.00	1.98 – 2.02
Phase 1b: LGX818 200 mg + Cetuximab	1.99	0.97 – 2.05
Phase 1b: LGX818 400 mg + Cetuximab	2.03	1.00 – 4.00
Phase 1b: LGX818 450 mg + Cetuximab	2.17	1.00 – 5.97
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab	1.00	0.98 – 1.98
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab	2.02	1.00 – 4.02
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab	2.00	0.87 – 5.95
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab	3.87	1.50 – 4.13
Phase 2: LGX818 200 mg + Cetuximab	2.00	0.93 – 6.12
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab	2.03	0.50 – 8.00

Adverse events — posted to ClinicalTrials.gov

Time frame: From screening up to 30 days after the last dose of study treatment (maximum up to 43 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1b: LGX818 100 mg + Cetuximab

Serious: 2/2 (100%)

Deaths: —

Phase 1b: LGX818 200 mg + Cetuximab

Serious: 5/7 (71%)

Deaths: —

Phase 1b: LGX818 400 mg + Cetuximab

Serious: 6/9 (67%)

Deaths: —

Phase 1b: LGX818 450 mg + Cetuximab

Serious: 6/8 (75%)

Deaths: —

Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab

Serious: 2/3 (67%)

Deaths: —

Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab

Serious: 5/8 (63%)

Deaths: —

Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab

Serious: 6/10 (60%)

Deaths: —

Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab

Serious: 4/7 (57%)

Deaths: —

Phase 2: LGX818 200 mg + Cetuximab

Serious: 25/50 (50%)

Deaths: —

Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab

Serious: 33/52 (63%)

Deaths: —

Serious adverse events (110 terms)

Reaction	System	Phase 1b: LGX818 100 mg + …	Phase 1b: LGX818 200 mg + …	Phase 1b: LGX818 400 mg + …	Phase 1b: LGX818 450 mg + …	Phase 1b: LGX818 200 mg + …	Phase 1b: LGX818 200 mg + …	Phase 1b: LGX818 200 mg + …	Phase 1b: LGX818 300 mg + …	Phase 2: LGX818 200 mg + C…	Phase 2: LGX818 200 mg + B…
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Subileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—
Cholangitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Ventricular fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—

Other adverse events (460 terms — click to expand)

Reaction	System	Phase 1b: LGX818 100 mg + …	Phase 1b: LGX818 200 mg + …	Phase 1b: LGX818 400 mg + …	Phase 1b: LGX818 450 mg + …	Phase 1b: LGX818 200 mg + …	Phase 1b: LGX818 200 mg + …	Phase 1b: LGX818 200 mg + …	Phase 1b: LGX818 300 mg + …	Phase 2: LGX818 200 mg + C…	Phase 2: LGX818 200 mg + B…
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Dermatitis acneiform	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Paronychia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Infusion related reaction, Vomiting, Pyrexia, Malignant melanoma, Ileus, Constipation, Pneumonia.

Data from ClinicalTrials.gov NCT01719380 adverse events section.

Sponsor's own description

This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer

Publications & conference data

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

Comprehensive review of targeted therapy for colorectal cancer.
Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
Targeting PI3K in cancer: mechanisms and advances in clinical trials.
Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x
Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
Cancer biomarker discovery and validation.
Goossens N, Nakagawa S, Sun X, Hoshida Y. · · 2015 · cited 360× · PMID 26213686 · DOI 10.3978/j.issn.2218-676x.2015.06.04
Combine and conquer: challenges for targeted therapy combinations in early phase trials.
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Bypass mechanisms of resistance to receptor tyrosine kinase inhibition in lung cancer.
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A Phase Ib Dose-Escalation Study of Encorafenib and Cetuximab with or without Alpelisib in Metastatic <i>BRAF</i>-Mutant Colorectal Cancer.
van Geel RMJM, Tabernero J, Elez E, Bendell JC, et al · · 2017 · cited 194× · PMID 28363909 · DOI 10.1158/2159-8290.cd-16-0795

Verify or expand the search:

Other trials of LGX818

Trials testing the same drug.

NCT02631447 — Sequential Combo Immuno and Target Therapy (SECOMBIT) Study · Phase 2 · completed
NCT02159066 — LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma · Phase 2 · completed
NCT01981187 — LGX818 for Patients With BRAFV600 Mutated Tumors · Phase 2 · terminated
NCT01909453 — Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma · Phase 3 · completed
NCT01543698 — A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors · Phase 1, PHASE2 · completed

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

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 NCT01719380 (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 Pfizer
Last refreshed: 23 June 2021

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/NCT01719380.

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

NCT01719380

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

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Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

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Sponsor's own description

Publications & conference data

Related trials

Other trials of LGX818

Other recruiting trials for Colorectal Cancer

Other Pfizer trials

Verify against primary sources