Mirdametinib for Breast Cancer

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity), Commack, NY
Breast Cancer+6 More ConditionsMirdametinib - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing if mirdametinib is a safe treatment for people with advanced solid tumor cancer that has certain mutations.

Eligible Conditions
  • MEK1 Gene Mutation
  • Breast Cancer
  • MEK2 Gene Mutation
  • Breast Cancer Stage IV
  • Solid Cancer
  • Metastatic Breast Cancer
  • HER2-negative Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Similar Trials

1
Inavolisib
1
RLY-2608
1
RLY-5836 + Fulvestrant Arm

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 28 days from first day of treatment

Day 28
Dose Limiting Treatment/DLT Evaluable Population

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Inavolisib
1
RLY-2608
1
RLY-5836 + Fulvestrant Arm

Side Effects for

Dovitinib
50%DECREASED APPETITE
30%CONSTIPATION
30%PAIN IN EXTREMITY
30%RASH
30%DIARRHOEA
20%OEDEMA PERIPHERAL
20%ANAEMIA
20%FATIGUE
20%COUGH
20%HEADACHE
20%ANGINA PECTORIS
20%GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%NASOPHARYNGITIS
10%PNEUMOTHORAX
10%PYREXIA
10%HERPES ZOSTER
10%HYPERKALAEMIA
10%NEURALGIA
10%RESTLESSNESS
10%INSOMNIA
10%PLEURAL EFFUSION
10%BLOOD ALKALINE PHOSPHATASE INCREASED
10%CORONARY ARTERY DISEASE
10%BRADYCARDIA
10%PNEUMONIA
10%NAUSEA
10%GASTROOESOPHAGEAL REFLUX DISEASE
10%ABDOMINAL PAIN
10%FACE OEDEMA
10%DYSPEPSIA
10%PLATELET COUNT DECREASED
10%ARTHRITIS
10%ASPARTATE AMINOTRANSFERASE INCREASED
10%MUSCULOSKELETAL PAIN
10%INTERNATIONAL NORMALISED RATIO INCREASED
10%HYPERTRIGLYCERIDAEMIA
10%MUSCLE SPASMS
10%DYSPNOEA
10%DYSPNOEA EXERTIONAL
10%SKIN LESION
10%MYOCARDIAL ISCHAEMIA
10%EYE OEDEMA
10%LEUKOPENIA
10%INCREASED TENDENCY TO BRUISE
10%NEUTROPENIA
10%ASTHENIA
10%INFLUENZA
10%CONTUSION
10%LYMPHOCYTE COUNT DECREASED
10%HYPOCALCAEMIA
10%ARTHRALGIA
10%PRURITUS
10%BLOOD CREATININE INCREASED
10%HYPOTHYROIDISM
10%PRODUCTIVE COUGH
10%DRY MOUTH
This histogram enumerates side effects from a completed 2016 Phase 2 & 3 trial (NCT02116803) in the Dovitinib ARM group. Side effects include: DECREASED APPETITE with 50%, CONSTIPATION with 30%, PAIN IN EXTREMITY with 30%, RASH with 30%, DIARRHOEA with 30%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

4 Treatment Groups

Arm 1, Part 1 - mirdametinib in combination with fulvestrant
1 of 4
Arm 1, Part 2 - mirdametinib in combination with fulvestrant
1 of 4
Arm 2, Part 1 - mirdametinib as single agent
1 of 4
Arm 2, Part 2 - mirdametinib as single agent
1 of 4

Experimental Treatment

150 Total Participants · 4 Treatment Groups

Primary Treatment: Mirdametinib · No Placebo Group · Phase 1 & 2

Arm 1, Part 1 - mirdametinib in combination with fulvestrantExperimental Group · 2 Interventions: Mirdametinib, Fulvestrant · Intervention Types: Drug, Drug
Arm 1, Part 2 - mirdametinib in combination with fulvestrantExperimental Group · 2 Interventions: Mirdametinib, Fulvestrant · Intervention Types: Drug, Drug
Arm 2, Part 1 - mirdametinib as single agent
Drug
Experimental Group · 1 Intervention: Mirdametinib · Intervention Types: Drug
Arm 2, Part 2 - mirdametinib as single agent
Drug
Experimental Group · 1 Intervention: Mirdametinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days from first day of treatment

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,865 Previous Clinical Trials
591,494 Total Patients Enrolled
194 Trials studying Breast Cancer
93,968 Patients Enrolled for Breast Cancer
Ezra Rosen, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Are there other research papers that mention Mirdametinib?

"Mirdametinib was first studied in the year 2004 at Lowell General Hospital. To date there are a total of 89 completed clinical trials with 140 more currently underway. There is significant research being conducted out of Harrison, New York." - Anonymous Online Contributor

Unverified Answer

Is this study also taking place in other hospitals throughout Canada?

"There are 6 locations where this clinical trial is being conducted; these include Harrison, Commack and New York. If you decide to participate in this study, the investigators will work with you to select a site that is close to your home to minimize travel burden." - Anonymous Online Contributor

Unverified Answer

Are volunteers being sought for this clinical trial at the moment?

"The information available on clinicaltrials.gov supports that this trial is ongoing and looking for new participants. This particular study was first publicized on September 14th, 2021 with the most recent update being from September 13th, 2022. They are aiming to have 150 people enrolled from 6 different locations." - Anonymous Online Contributor

Unverified Answer

How many men and women are enrolled in this research project?

"That is correct, the clinicaltrials.gov website does show that this trial is open for recruitment. The listing shows that the study was first posted on September 14th, 2021 and was last updated on September 13th, 2022. They are looking for a total of 150 participants across 6 different sites." - Anonymous Online Contributor

Unverified Answer

What are the primary indications for Mirdametinib?

"Mirdametinib, while commonly used to treat endocrine conditions, can also be effective in treating other diseases such as breast cancer and those with a pik3ca gene mutation." - 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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