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Binimetinib for Melanoma

University of California, San Francisco, San Francisco, CA
Melanoma+1 More ConditionsBinimetinib - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is studying how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery.

Eligible Conditions
  • Melanoma Stage III
  • Metastatic Melanoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
binimetinib
1
Intervention arm
1
Encorafenib

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Clinical benefit rate (CBR)
Median duration of response
Overall survival (OS)
Progression-free survival (PFS)
Proportion of participants with treatment-related adverse events (AE)
Up to week 16
Objective response rate (ORR)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
binimetinib
2
Intervention arm
2
Encorafenib

Side Effects for

Phase 3:Control Arm
48%Diarrhoea
41%Nausea
39%Dermatitis acneiform
29%Vomiting
27%Fatigue
27%Decreased appetite
25%Asthenia
25%Abdominal pain
23%Stomatitis
19%Anaemia
19%Neutropenia
18%Constipation
14%Rash
14%Hypokalaemia
14%Pyrexia
12%Back Pain
11%Neutrophil count decreased
9%Dyspnoea
9%Paronychia
9%Hypomagnesaemia
8%Abdominal pain upper
8%Dizziness
7%Oedema peripheral
7%Palmar-planar erythrodysaesthesia
7%PPE syndrome
7%White blood cell count decrease
7%Infusion related reaction
7%Dry Skin
7%Aspartate aminotransferase increased
6%Rash maculo-papular
6%Insomnia
6%Weight decreased
6%Malaise
6%Alanine aminotransferase increased
5%Skin fissures
5%Cough
5%Pruritus
4%Dyspepsia
4%Dry Mouth
4%Abdominal distension
4%Pulmonary embolism
4%Dysgeusia
4%Intestinal obstruction
4%Blood bilirubin increased
4%Dehydration
4%Epistaxis
3%Hyperglycaemia
3%Infusion-related reaction
3%Urinary tract infection
3%Neuropathy peripheral
3%Febrile neutropenia
3%Hypoalbuminaemia
3%Hypertension
3%Small intestinal obstruction
3%Gastroesophageal reflux disease
3%Headache
2%Haematuria
2%Hypotension
2%Subileus
2%Myalgia
2%Flatulence
2%Dysphonia
2%Rash pustular
2%Peripheral sensory neuropathy
2%Musculoskeletal pain
2%Erythema
2%Chills
2%Blood creatine phosphokinase increased
2%Respiratory failure
2%Muscle spasms
1%Jaundice
1%Pain
1%Skin lesion
1%Hydronephrosis
1%Conjunctivitis
1%Cystitis
1%Anal abscess
1%Abdominal hernia
1%Bacteraemia
1%Colon cancer metastatic
1%Neoplasm progression
1%Cardio-respiratory
1%Colorectal cancer
1%Peritonitis
1%Anaphylactic reaction
1%Respiratory tract infection
1%Respiratory distress
1%Cancer pain
1%Proctalgia
1%Vision blurred
1%Arthralgia
1%Pain in extremity
1%Dry eye
1%Acute kidney injury
1%Depression
1%Palpitations
1%Tumour Pain
1%Enterocolitis
1%Epilepsy
1%Large intestine perforation
1%Cerebral ischaemia
1%Bile duct obstruction
1%Rectal haemorrhage
1%Rhinnorrhoea
1%Ileus
1%Bacteria sepsis
1%Abscess limb
1%General physical health deterioration
1%Campylobacter gastroenteritis
1%Blood creatine increased
1%Ascites
1%Skin hyperpigmentation
1%Eczema
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02928224) in the Phase 3:Control Arm ARM group. Side effects include: Diarrhoea with 48%, Nausea with 41%, Dermatitis acneiform with 39%, Vomiting with 29%, Fatigue with 27%.

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 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

1 Treatment Group

Treatment (binimetinib, imatinib)
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Binimetinib · No Placebo Group · Phase 2

Treatment (binimetinib, imatinib)Experimental Group · 2 Interventions: Binimetinib, Imatinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
FDA approved
Imatinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,590 Total Patients Enrolled
5 Trials studying Melanoma
222 Patients Enrolled for Melanoma
University of California, San FranciscoLead Sponsor
2,347 Previous Clinical Trials
11,783,087 Total Patients Enrolled
11 Trials studying Melanoma
408 Patients Enrolled for Melanoma
Katy Tsai, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Melanoma
24 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are using an intra-uterine device (IUD).
You currently have an intrauterine hormone-releasing device (IUS) in place.
You are using a type of birth control that only contains progesterone and works by stopping ovulation. This includes pills, injections, and implants.
You have received immunotherapy as part of your previous cancer treatment, but your last dose was given at least 4 weeks before starting this study.
You have received immunotherapy for unresectable or metastatic disease, but your last dose was at least 4 weeks before starting the study drug.
You can participate even if you have brain metastases or leptomeningeal disease, as long as your doctor decides that you do not need immediate treatment for your condition before starting the study.
You are eligible for the trial if you had a previous or current cancer that does not impact the assessment of the new treatment's safety or effectiveness.
If your partner becomes pregnant while you're in the study, tell your doctor right away.
You are not allowed to have sex with a partner of the opposite gender.
References

Frequently Asked Questions

What are the potential risks of Binimetinib to patients?

"The safety rating of Binimetinib is a 2, as there has been some evidence to support its safety profile but no data demonstrating efficacy in clinical trials." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor actively enlisting participants?

"The current status of the medical trial, as per clinicaltrials.gov, is actively recruiting patients. It was first listed on March 3rd 2021 and recently updated on December 3rd 2021." - Anonymous Online Contributor

Unverified Answer

Have any other investigations utilized Binimetinib?

"Currently, there are 110 studies regarding binimetinib in progress with 18 of those trials having progressed to phase 3. While Cambridge England hosts several of these investigations, clinical trails related to Binimetinib can be found at 4,872 distinct sites worldwide." - Anonymous Online Contributor

Unverified Answer

What conditions can Binimetinib provide relief for?

"Binimetinib is primarily employed to treat newly diagnosed acute lymphoblastic leukaemia. Other conditions that may benefit from this pharmaceutical include unresectable melanoma, refractory ALL, and muscular dystrophy." - Anonymous Online Contributor

Unverified Answer

What is the aggregate size of this research cohort?

"Correct. Clinicaltrials.gov verifies that this research project, initially posted on March 3rd 2021, is now actively accepting participants. 25 volunteers are sought from a single medical site." - 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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