Cobimetinib for Refractory Acute Myelogenous Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CARefractory Acute Myelogenous Leukemia+1 MoreCobimetinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Refractory Acute Myelogenous Leukemia
  • Acute Recurrent Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
ASTX727
1
Decitabine and Cedazuridine
1
Navitoclax

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 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

Cycle 1 (28 days)
Dose limiting toxicity
Year 1
Response duration
Year 3
Time to first response
Year 1
Overall survival (OS)
Year 1
Event-free survival (EFS)
Year 1
Changes in RAS pathway regulatory gene expression levels
Up to 1 year
Complete remission
Level of myeloid differentiation
Minimal residual disease (MRD) status
Promotor methylation status of RAS pathway regulator
Response
Day 30
Incidence of adverse events

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
ASTX727
1
Decitabine and Cedazuridine
1
Navitoclax

Side Effects for

Regorafenib
53%PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
48%FATIGUE
43%DECREASED APPETITE
38%DIARRHOEA
31%HYPERTENSION
26%ABDOMINAL PAIN
25%PYREXIA
24%DYSPHONIA
21%ASTHENIA
21%CONSTIPATION
21%WEIGHT DECREASED
21%RASH
16%STOMATITIS
16%DYSPNOEA
15%NAUSEA
13%HEADACHE
11%VOMITING
10%BACK PAIN
10%ANAEMIA
10%COUGH
9%ASPARTATE AMINOTRANSFERASE INCREASED
9%HYPOPHOSPHATAEMIA
9%MYALGIA
9%EPISTAXIS
8%MUCOSAL INFLAMMATION
8%MUSCLE SPASMS
8%PAIN IN EXTREMITY
8%LIPASE INCREASED
6%ALANINE AMINOTRANSFERASE INCREASED
6%BLOOD CREATININE INCREASED
6%HYPOCALCAEMIA
6%ARTHRALGIA
6%OROPHARYNGEAL PAIN
6%ERYTHEMA
5%CHEST PAIN
5%DRY MOUTH
5%PROCTALGIA
5%CHILLS
5%URINARY TRACT INFECTION
5%BLOOD BILIRUBIN INCREASED
5%BLOOD THYROID STIMULATING HORMONE INCREASED
5%MUSCULOSKELETAL PAIN
4%BLOOD CREATINE PHOSPHOKINASE INCREASED
4%OEDEMA PERIPHERAL
4%UPPER RESPIRATORY TRACT INFECTION
4%HYPOKALAEMIA
4%DIZZINESS
4%INSOMNIA
4%RASH MACULO-PAPULAR
3%INTESTINAL PERFORATION
3%SEPSIS
3%THROMBOCYTOPENIA
3%DERMATITIS ACNEIFORM
3%PRURITUS
3%ABDOMINAL PAIN UPPER
1%ATRIAL FIBRILLATION
1%LEFT VENTRICULAR DYSFUNCTION
1%ANAL HAEMORRHAGE
1%GASTROINTESTINAL HAEMORRHAGE
1%LOWER GASTROINTESTINAL HAEMORRHAGE
1%DEATH
1%VAGINAL HAEMORRHAGE
1%BLOOD ALKALINE PHOSPHATASE INCREASED
1%DRY SKIN
1%COLONIC FISTULA
1%STREPTOCOCCAL BACTERAEMIA
1%HYPONATRAEMIA
1%PYELONEPHRITIS
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT02788279) in the Regorafenib ARM group. Side effects include: PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME with 53%, FATIGUE with 48%, DECREASED APPETITE with 43%, DIARRHOEA with 38%, HYPERTENSION with 31%.

Trial Design

1 Treatment Group

Treatment (cobimetinib, enasidenib mesylate)
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Cobimetinib · No Placebo Group · Phase 1

Treatment (cobimetinib, enasidenib mesylate)Experimental Group · 2 Interventions: Cobimetinib, Enasidenib Mesylate · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
2015
Completed Phase 3
~2380

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
524 Previous Clinical Trials
2,249,963 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,152 Previous Clinical Trials
41,162,984 Total Patients Enrolled
Brian BallPrincipal InvestigatorCity of Hope Medical Center

Eligibility Criteria

Age 18+ · All Participants · 25 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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