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EGFR Inhibitor

MEK162 for Lung Cancer

Phase 1

Waitlist Available

Led By Jhanelle Gray, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will test if the combination of MEK162 and erlotinib is safe and if it has any benefits for patients with NSCLC.

Eligible Conditions

Lung Cancer
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Maximum Tolerated Dose (MTD)

Secondary outcome measures

Number of Participants with Overall Survival (OS)

Number of Participants with Progression Free Survival (PFS)

Side effects data

From 2019 Phase 3 trial • 402 Patients • NCT01763164

44%

BLOOD CREATINE PHOSPHOKINASE INCREASED

41%

DIARRHOEA

39%

DERMATITIS ACNEIFORM

36%

OEDEMA PERIPHERAL

36%

RASH

32%

NAUSEA

25%

FATIGUE

22%

VOMITING

16%

ASTHENIA

14%

CONSTIPATION

14%

ASPARTATE AMINOTRANSFERASE INCREASED

14%

DRY SKIN

13%

PYREXIA

13%

RETINAL DETACHMENT

13%

EJECTION FRACTION DECREASED

13%

DECREASED APPETITE

13%

HYPERTENSION

10%

EYELID OEDEMA

10%

SKIN FISSURES

10%

MYALGIA

10%

DYSPNOEA

10%

PRURITUS

ABDOMINAL PAIN

ALANINE AMINOTRANSFERASE INCREASED

ALOPECIA

RASH MACULO-PAPULAR

DRY MOUTH

DYSGEUSIA

ANAEMIA

SUBRETINAL FLUID

BACK PAIN

ARTHRALGIA

HEADACHE

RASH PUSTULAR

VISION BLURRED

INTRAOCULAR PRESSURE INCREASED

COUGH

ABDOMINAL PAIN UPPER

PERIPHERAL SWELLING

MACULAR OEDEMA

NECK PAIN

DIZZINESS

MUSCULAR WEAKNESS

ERYTHEMA

NASOPHARYNGITIS

INSOMNIA

ERYSIPELAS

PERIORBITAL OEDEMA

FACE OEDEMA

WEIGHT DECREASED

PAIN IN EXTREMITY

GENERAL PHYSICAL HEALTH DETERIORATION

LYMPHOPENIA

GAMMA-GLUTAMYLTRANSFERASE INCREASED

SKIN INFECTION

PULMONARY EMBOLISM

RENAL FAILURE

HYPERTENSIVE CRISIS

RETINAL VEIN THROMBOSIS

SPINAL CORD COMPRESSION

CELLULITIS

SEPSIS

INTERVERTEBRAL DISC PROTRUSION

NEUTROPENIA

THROMBOCYTOPENIA

HAEMORRHAGE

CONFUSIONAL STATE

PNEUMONITIS

PYELONEPHRITIS ACUTE

SOFT TISSUE INFECTION

UROSEPSIS

PLATELET COUNT DECREASED

RETINAL VEIN OCCLUSION

100%

80%

60%

40%

20%

Study treatment Arm

Binimetinib (MEK162)

Dacarbazine

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase I - Dose EscalationExperimental Treatment2 Interventions

For the Phase I portion, patients will start MEK162 by mouth (p.o.) on cycle 1, day 1 and erlotinib on cycle 1, day 2. The MEK162 will be dosed once daily (QD) or twice (b.i.d.), and erlotinib will be dosed daily (QD) on a 28-day cycle. Phase I will be followed by an expansion Phase Ib.

Group II: Arm B: Dose ExpansionExperimental Treatment2 Interventions

Phase Ib Arm B: KRAS Mutant Tumor Status. In the phase IB expansion cohort study there are 2 arms based on the presence of the EGFR (Arm A) or KRAS (Arm B) mutation. The treatments for each arm are the same: MEK162 (2 time a day) and erlotinib (once) daily on 28 day cycles.

Group III: Arm A: Dose ExpansionExperimental Treatment2 Interventions

Phase Ib Arm A: EGFR Mutant Tumor Status. In the phase IB expansion cohort study there are 2 arms based on the presence of the EGFR (Arm A) or KRAS (Arm B) mutation. The treatments for each arm are the same: MEK162 (2 time a day) and erlotinib (once) daily on 28 day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MEK162

2013

Completed Phase 3

~1520

Erlotinib

2011

Completed Phase 4

~2290

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,449 Total Patients Enrolled

Array BioPharmaIndustry Sponsor

28 Previous Clinical Trials

1,354 Total Patients Enrolled

Jhanelle Gray, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

6 Previous Clinical Trials

331 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other case studies that have applied MEK162?

"Presently, 152 active trials are researching MEK162 with 12 of those being within Phase 3. Most of these studies are situated in Melbourne, Victoria; however, 12319 sites around the world are scrutinizing this medication."

Answered by AI

What are the common applications of MEK162?

"MEK162 is typically prescribed to treat metastatic melanoma, malignant neoplasms, and pancreatic carcinoma. Unresectable melanomas can also benefit from this medication's use."

Answered by AI

Are there any available slots for individuals to participate in this research?

"This research has ceased participant recruitment as of August 15th, 2022. It was initially posted on December 30th 2013. However, 2179 studies recruiting participants with carcinoma and non-small-cell lung cancer are available along with 152 trials for MEK162 still accepting enrollments."

Answered by AI

What is the current government sanctioning status of MEK162?

"Our experts at Power have rated MEK162's safety level as a 1 due to the limited amount of evidence demonstrating its efficacy and security."

Answered by AI

How many participants is the trial seeking to enroll?

"The recruitment period for this clinical trial has since terminated. It was initially advertised on December 30th 2013, and the listing had been edited till August 15th 2022. If you are researching other medical trials, there are 2179 studies recruiting patients with carcinoma non-small cell lung while 152 trials require participants to test MEK 162."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/IB Trial of MEK162 in Combination With Erlotinib in NSCLC Harboring KRAS or EGFR Mutation

2013. "A Phase I/IB Trial of MEK162 in Combination With Erlotinib in NSCLC Harboring KRAS or EGFR Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01859026.