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MEK Inhibitor

Cobimetinib for Histiocytic Disorders

Phase 2

Waitlist Available

Led By Eli Diamond, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will study the effects of Cobimetinib in patients with histiocytosis. Cobimetinib is an oral medication that blocks MEK1.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Best Overall Response

Side effects data

From 2024 Phase 2 trial • 86 Patients • NCT03201458

74%

Disease Progression

47%

Fatigue

35%

Aspartate aminotransferase (AST) increased

33%

Abdominal pain

33%

Diarrhea

30%

Hypertension

30%

Lymphocyte count decreased

30%

Anemia

28%

Hyponatremia

28%

Alkaline phosphatase increased

28%

Nausea

26%

Hypoalbuminemia

26%

Hypokalemia

23%

Alanine aminotransferase (ALT) increased

23%

Vomiting

21%

Fever

21%

Platelet count decreased

21%

Anorexia

21%

Cough

19%

Pain

16%

Blood bilirubin increased

16%

Constipation

16%

White blood cell decreased

14%

Dyspnea

14%

Creatinine increased

12%

Hypomagnesemia

12%

Bloating

12%

Chills

12%

Dehyrdation

12%

Weight loss

Hypothyroidism

Rash

Dizziness

Edema

Headache

Infusion-related reaction

Hypotension

Ascites

Back pain

Hypophosphotemia

Allergic reaction

Neutrophil count decreased

Dyspepsia

Thrush

Hypercalcemia

Hyperglycemia

Hypocalcemia

Myalgia

Gastric obstruction

Insomnia

Malaise

Proteinuria

Allergic rhinitis

Dysgeusia

Dysphagia

Flatulence

Generalized muscle weakness

Non-cardiac chest pain

Oral pain

Peripheral neuropathy

Pleural effusion

Pruritus

Sinus tachycardia

Colitis

Death NOS

Abdominal distension

Anxiety

Arthralgia

Hyperhidrosis

Gastroesophageal reflux disease (GERD)

Biliary tract infection

Presyncope

Myocarditis

Biliary duct obstruction

Hyperkalemia

Syncope

Cardiac troponin increased

Duodenal obstruction

Lipase increased

Pleuritic pain

Edema limbs

Encephalopathy

Hypoxia

Ileal obstruction

Myocardial infarction

Sepsis

Ureteral obstruction

Urinary retention

Dry mouth

Dry skin

Sinus bradycardia

Sore throat

Bacteremia

Fungemia

Infusion related reaction

Meningitis

Peritoneal infection

Viral infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm A (Atezolizumab)

Arm B (Atezolizumab, Cobimetinib)

Trial Design

1Treatment groups

Experimental Treatment

Group I: CobimetinibExperimental Treatment1 Intervention

This is an open-label, multicenter, phase II study exploring the efficacy and safety of single-agent Cobimetinib in patients with histiocytic disorders whose tumors are 1) BRAFV600 wildtype or 2) BRAFV600E mutant and are intolerant to, or unable to access, BRAF inhibitors. Visits during the treatment period are to be completed on Day 1, Day 15 (this visit can be by telephone), Day 29, and every 28 days thereafter. For patients treated on the study for six months, at the discretion of the Principal Investigator, visits can be spaced out to every 56 days (every 2 cycles instead of every cycle). After 24 cycles of treatment, if imaging demonstrates sustained stability in the opinion of the principal investigator, tumor assessments can be performed ever 1 year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cobimetinib

2017

Completed Phase 3

~2660

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Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,344 Total Patients Enrolled

1 Trials studying Histiocytic Disorders

3 Patients Enrolled for Histiocytic Disorders

Genentech, Inc.Industry Sponsor

1,538 Previous Clinical Trials

567,693 Total Patients Enrolled

Eli Diamond, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

840 Total Patients Enrolled

1 Trials studying Histiocytic Disorders

3 Patients Enrolled for Histiocytic Disorders

Frequently Asked Questions

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

Are there any other research initiatives that used Cobimetinib?

"Cobimetinib was first investigated in 2013 at Local Institution - 0046, with 30 studies having since concluded. Currently, there are 55 ongoing trials happening around the world including several conducted out of Rochester, Minnesota."

Answered by AI

Has a similar experiment been conducted before?

"Presently, there are fifty-five active studies for Cobimetinib across 354 cities and forty-eight countries. The initial investigation of this drug, sponsored by Bristol-Myers Squibb, started in 2013; it involved 1163 individuals and finished its Phase 1 & 2 trial stage. Since then another thirty trials have been executed."

Answered by AI

How many participants are contributing to this clinical trial?

"Affirmative. Clinicaltrials.gov lists this medical study as currently recruiting patients, having been posted on January 1st 2016 and revised August 2nd 2022. To fill out the requirements of this experiment, 55 participants need to be sourced from two distinct facilities."

Answered by AI

Are there still slots available for prospective volunteers in this experiment?

"This medical experiment, initially introduced on January 1st 2016 and most recently updated on August 2nd 2022, is currently recruiting patients according to clinicaltrials.gov."

Answered by AI

What potential side effects should one consider before taking Cobimetinib?

"Preliminary studies suggest that cobimetinib is relatively safe, leading our team to assign it an estimated safety score of 2. This rating takes into account the fact that this trial exists at a Phase 2 level and only has limited data supporting its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single-agent Cobimetinib for Adults With Histiocytic Disorders

2016. "Single-agent Cobimetinib for Adults With Histiocytic Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02649972.