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Kinase Inhibitor
Enasidenib + Cobimetinib for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Brian Ball
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: >= 18 years
Have a confirmed susceptible IDH2 mutation (R140 or R172) with a concomitant RAS-pathway mutation, involving NRAS, KRAS, PTPN11, CBL or NF1 genes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first study dose to first documented complete response to relapse/progression (> 5% blasts, reappearance of blasts in blood, or development of extramedullary disease) or death, whichever occurs first, assessed up to 1 year
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a combination of two drugs, enasidenib and cobimetinib, for patients with acute myeloid leukemia that has returned or does not respond to treatment.
Who is the study for?
Adults with relapsed or refractory acute myeloid leukemia (AML) who have specific IDH2 and RAS-pathway mutations can join this trial. They must be able to swallow pills, not be on high-dose steroids or immunosuppressants, and should not have other active cancers or serious heart conditions. Women of childbearing age need a negative pregnancy test and agree to use non-hormonal birth control.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Enasidenib, which blocks enzymes that cancer cells need to grow; and Cobimetinib, a kinase inhibitor that stops mutated proteins from multiplying cancer cells. The goal is to find the safest dose that effectively kills more AML cancer cells.See study design
What are the potential side effects?
Potential side effects may include liver issues reflected in blood tests, heart problems like changes in ejection fraction or rhythm disturbances, increased risk of infection due to lowered immune response, digestive system discomforts such as nausea or diarrhea, fatigue, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My cancer has specific IDH2 and RAS-pathway mutations.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have recovered from side effects of cancer treatment, except for hair loss.
Select...
My AML is not responding to treatment and I can't have known effective therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first study dose to first documented complete response to relapse/progression (> 5% blasts, reappearance of blasts in blood, or development of extramedullary disease) or death, whichever occurs first, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first study dose to first documented complete response to relapse/progression (> 5% blasts, reappearance of blasts in blood, or development of extramedullary disease) or death, whichever occurs first, assessed up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity
Incidence of adverse events
Secondary outcome measures
Complete remission
Event-free survival (EFS)
Minimal residual disease (MRD) status
+4 moreOther outcome measures
Changes in RAS pathway regulatory gene expression levels
Level of myeloid differentiation
Promotor methylation status of RAS pathway regulator
Side effects data
From 2024 Phase 2 trial • 86 Patients • NCT0320145874%
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
9%
Hypothyroidism
9%
Rash
9%
Dizziness
9%
Edema
9%
Headache
9%
Infusion-related reaction
9%
Hypotension
9%
Ascites
7%
Back pain
7%
Hypophosphotemia
7%
Allergic reaction
7%
Neutrophil count decreased
7%
Dyspepsia
7%
Thrush
7%
Hypercalcemia
7%
Hyperglycemia
5%
Hypocalcemia
5%
Myalgia
5%
Gastric obstruction
5%
Insomnia
5%
Malaise
5%
Proteinuria
5%
Allergic rhinitis
5%
Dysgeusia
5%
Dysphagia
5%
Flatulence
5%
Generalized muscle weakness
5%
Non-cardiac chest pain
5%
Oral pain
5%
Peripheral neuropathy
5%
Pleural effusion
5%
Pruritus
5%
Sinus tachycardia
5%
Colitis
5%
Death NOS
5%
Abdominal distension
5%
Anxiety
5%
Arthralgia
5%
Hyperhidrosis
2%
Biliary tract infection
2%
Gastroesophageal reflux disease (GERD)
2%
Presyncope
2%
Myocarditis
2%
Biliary duct obstruction
2%
Hyperkalemia
2%
Syncope
2%
Cardiac troponin increased
2%
Duodenal obstruction
2%
Lipase increased
2%
Pleuritic pain
2%
Edema limbs
2%
Encephalopathy
2%
Hypoxia
2%
Ileal obstruction
2%
Myocardial infarction
2%
Sepsis
2%
Ureteral obstruction
2%
Urinary retention
2%
Dry mouth
2%
Dry skin
2%
Sinus bradycardia
2%
Sore throat
2%
Bacteremia
2%
Fungemia
2%
Infusion related reaction
2%
Meningitis
2%
Peritoneal infection
2%
Viral infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Atezolizumab)
Arm B (Atezolizumab, Cobimetinib)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cobimetinib, enasidenib mesylate)Experimental Treatment2 Interventions
Patients receive cobimetinib PO QD on days 1-21 and enasidenib mesylate PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,645 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,839 Total Patients Enrolled
Brian BallPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have an IDH2 mutation and was treated with enasidenib.I have severe limitations due to heart problems.I have an active brain or spinal cord condition.I have a serious illness that is not under control.I am not pregnant or breastfeeding.My cancer has specific IDH2 and RAS-pathway mutations.I agree to use non-hormonal birth control or abstain from sex starting 4 weeks before and until 2 months after my last treatment dose.My heart rhythm issue is stable, or I have controlled, symptom-free atrial fibrillation.I have a condition that affects how my body absorbs medication taken by mouth.I can take care of myself but might not be able to do heavy physical work.My kidney function test shows a creatinine clearance of 50 mL/min or more.I am capable of having children and agree not to donate sperm or conceive during the study.I have recovered from side effects of cancer treatment, except for hair loss.I have eye conditions like retinopathy, retinal vein occlusion, or uncontrolled glaucoma.My AML is not responding to treatment and I can't have known effective therapies.I am not on high doses of steroids or any immunosuppressive drugs.I am currently taking antibiotics for an infection.I haven't used any experimental drugs or had major cancer treatments in the last 4 weeks.I haven't taken strong drugs that affect liver enzymes in the last 2 weeks.I haven't used any blood cell growth boosters in the last 14 days.I can swallow pills.I have not had a live-virus vaccine in the last 4 weeks.I do not have any other active cancer.I haven't consumed grapefruit, Seville oranges, starfruit, St. John's wort, or similar foods/supplements in the last 7 days.I haven't had a heart attack or unstable angina in the last 6 months.My cancer has spread outside the brain but also affects my bone marrow.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cobimetinib, enasidenib mesylate)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this medical study?
"As indicated on clinicaltrials.gov, this medical study is no longer accepting participants; it was initially posted on November 28th 2022 and last updated June 28th of that year. However, there are an array of other trials currently recruiting patients in the intervening period, standing at 1466 as of now."
Answered by AI
Has Cobimetinib been given regulatory clearance from the FDA?
"At Power, we rate the safety of Cobimetinib as a 1 due to this being an early-stage trial. This means there is limited evidence supporting both its efficacy and safety."
Answered by AI
What tangible results are anticipated to be achieved by this trial?
"The primary objective of this clinical trial, which will be monitored over the course of Cycle 1 (28 days), is to assess adverse events. Secondary outcomes include completeness of remission, time taken for first response, and duration of overall responses. To determine rates a 95% Clopper-Pearson binomial confidence interval will be calculated."
Answered by AI
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