CLINICAL TRIAL
Brigatinib for Brain Cancer
Grade I
Metastatic
Waitlist Available · 18+ · All Sexes · Duarte, CA
This study is evaluating whether a drug may help treat brain cancer.
See full descriptionAbout the trial for Brain Cancer
Eligible Conditions
Brain Neoplasms · Lung Cancers · Lung Neoplasms · Neoplasm Metastasis · Tumors Metastatic to Brain
Treatment Groups
This trial involves 2 different treatments. Brigatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Brigatinib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
About The Treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brigatinib
FDA approved
Side Effect Profile for Randomized Phase: Brigatinib 90 mg QD/180 QD
Randomized Phase: Brigatinib 90 mg QD/180 QD
Show all side effects
57%
Diarrhoea
50%
Blood Creatine Phosphokinase Increased
36%
Cough
32%
Hypertension
32%
Nausea
26%
Back Pain
26%
Aspartate Aminotransferase Increased
23%
Headache
23%
Dyspnoea
23%
Alanine Aminotransferase Increased
23%
Lipase Increased
22%
Vomiting
21%
Pruritus
21%
Fatigue
20%
Arthralgia
19%
Constipation
18%
Rash
17%
Dizziness
15%
Pyrexia
15%
Muscle Spasms
13%
Asthenia
13%
Upper Respiratory Tract Infection
13%
Blood Alkaline Phosphatase Increased
13%
Abdominal Pain
12%
Decreased Appetite
11%
Dyspepsia
11%
Musculoskeletal Pain
10%
Insomnia
10%
Oropharyngeal Pain
10%
Blood Cholesterol Increased
10%
Myalgia
10%
Dermatitis Acneiform
10%
Oedema Peripheral
9%
Paraesthesia
9%
Stomatitis
9%
Musculoskeletal Chest Pain
9%
Productive Cough
9%
Nasopharyngitis
9%
Anaemia
8%
Abdominal Pain Upper
8%
Non-Cardiac Chest Pain
7%
Urinary Tract Infection
7%
Pneumonia
7%
Bradycardia
7%
Epistaxis
7%
Pain In Extremity
7%
Rash Erythematous
6%
Dry Mouth
6%
Dry Skin
6%
Eczema
6%
Dysphonia
6%
Electrocardiogram Qt Prolonged
6%
Blood Creatinine Increased
6%
Rash Maculo-Papular
5%
Respiratory Tract Infection
5%
Vision Blurred
5%
Hypophosphataemia
5%
Malaise
5%
Hypercholesterolaemia
5%
Sinus Bradycardia
5%
Hyperglycaemia
5%
Hypokalaemia
5%
Rhinorrhoea
5%
Blood Lactate Dehydrogenase Increased
4%
Dysgeusia
4%
Depression
4%
Gamma-Glutamyltransferase Increased
4%
Neoplasm Progression
4%
Influenza Like Illness
4%
Peripheral Swelling
2%
Taste Disorder
2%
Hypocalcaemia
2%
Pleural Effusion
2%
Hypotension
2%
Neutrophil Count Decreased
2%
Pulmonary Embolism
2%
Interstitial Lung Disease
2%
Hypoaesthesia
1%
Oesophageal Obstruction
1%
Hypoalbuminaemia
1%
Acute Kidney Injury
1%
Appendicitis
1%
Hepatocellular Injury
1%
Pneumonitis
1%
Acute Myocardial Infarction
1%
Vocal Cord Paralysis
1%
Toxicity To Various Agents
1%
Gout
1%
C-Reactive Protein Increased
1%
Hypoglycaemia
1%
Cancer Pain
1%
Muscular Weakness
1%
Dysphagia
1%
Gastrooesophageal Reflux Disease
1%
Transaminases Abnormal
1%
Femoral Neck Fracture
1%
Hyperkalaemia
1%
Pericardial Effusion
1%
Confusional State
1%
Multiple Organ Dysfunction Syndrome
1%
Ovarian Cancer Stage I
1%
Delirium
1%
Visual Impairment
1%
Gastric Haemorrhage
1%
Seizure
1%
Fall
1%
Ligament Rupture
1%
Photopsia
1%
Malignant Pleural Effusion
1%
Viral Infection
1%
Lower Respiratory Tract Infection
1%
Diffuse Large B-Cell Lymphoma
1%
Gastroenteritis
1%
Lung Adenocarcinoma
1%
Neutropenia
1%
Partial Seizures
1%
Cognitive Disorder
1%
Peripheral Sensory Neuropathy
1%
Invasive Breast Carcinoma
1%
Lung Neoplasm Malignant
1%
Memory Impairment
1%
Cardiac Tamponade
1%
Disseminated Intravascular Coagulation
1%
Syncope
1%
Pulmonary Oedema
1%
Metastases To Meninges
1%
Metastases To Central Nervous System
1%
Balance Disorder
1%
Squamous Cell Carcinoma Of Skin
1%
Cerebrovascular Accident
1%
Encephalopathy
1%
Pneumothorax
1%
Dysarthria
1%
Neutropenic Colitis
1%
Respiratory Distress
1%
Atrial Fibrillation
1%
Pneumonia Aspiration
1%
Cholecystitis
1%
Arrhythmia
1%
Angina Pectoris
1%
Inguinal Hernia
1%
Bile Duct Stone
1%
Cholestasis
1%
Mucosal Inflammation
1%
Sudden Death
0%
Aphasia
0%
Blood Insulin Increased
0%
Depressed Level Of Consciousness
0%
Tibia Fracture
0%
Intraventricular Haemorrhage
0%
Drug-Induced Liver Injury
0%
Palpitations
0%
Respiratory Arrest
0%
Deep Vein Thrombosis
0%
Cardiac Failure
0%
Covid-19
0%
Gastroenteritis Viral
0%
Prostate Cancer
0%
Intestinal Obstruction
0%
Atypical Pneumonia
0%
Herpes Zoster
0%
Respiratory Failure
0%
Intracranial Tumour Haemorrhage
0%
Amylase Increased
0%
Ascites
0%
Brain Herniation
0%
Abdominal Pain Lower
0%
Large Intestine Perforation
0%
Bone Pain
0%
Urinary Retention
0%
Oesophagitis Ulcerative
0%
Rotator Cuff Syndrome
0%
General Physical Health Deterioration
0%
Disorientation
0%
Salmonella Sepsis
0%
Cytomegalovirus Oesophagitis
0%
Cellulitis
0%
Listeriosis
0%
Pleural Infection
0%
Vertigo Positional
0%
Septic Shock
0%
Sinusitis Fungal
0%
Tumour Haemorrhage
0%
Hodgkins Disease
0%
Ischaemic Stroke
0%
Anaemia Macrocytic
0%
Central Nervous System Lesion
0%
Acute Respiratory Failure
0%
Myocardial Infarction
0%
Arthritis
0%
Menorrhagia
0%
Platelet Count Decreased
0%
Spinal Fracture
0%
Haematuria
0%
Hemiparesis
0%
Generalised Tonic-Clonic Seizure
0%
Performance Status Decreased
0%
Pyelonephritis Acute
0%
Anxiety
0%
Haemoptysis
Diarrhoea
57%
Blood Creatine Phosphokinase Increased
50%
Cough
36%
Hypertension
32%
Nausea
32%
Back Pain
26%
Aspartate Aminotransferase Increased
26%
Headache
23%
Dyspnoea
23%
Alanine Aminotransferase Increased
23%
Lipase Increased
23%
Vomiting
22%
Pruritus
21%
Fatigue
21%
Arthralgia
20%
Constipation
19%
Rash
18%
Dizziness
17%
Pyrexia
15%
Muscle Spasms
15%
Asthenia
13%
Upper Respiratory Tract Infection
13%
Blood Alkaline Phosphatase Increased
13%
Abdominal Pain
13%
Decreased Appetite
12%
Dyspepsia
11%
Musculoskeletal Pain
11%
Insomnia
10%
Oropharyngeal Pain
10%
Blood Cholesterol Increased
10%
Myalgia
10%
Dermatitis Acneiform
10%
Oedema Peripheral
10%
Paraesthesia
9%
Stomatitis
9%
Musculoskeletal Chest Pain
9%
Productive Cough
9%
Nasopharyngitis
9%
Anaemia
9%
Abdominal Pain Upper
8%
Non-Cardiac Chest Pain
8%
Urinary Tract Infection
7%
Pneumonia
7%
Bradycardia
7%
Epistaxis
7%
Pain In Extremity
7%
Rash Erythematous
7%
Dry Mouth
6%
Dry Skin
6%
Eczema
6%
Dysphonia
6%
Electrocardiogram Qt Prolonged
6%
Blood Creatinine Increased
6%
Rash Maculo-Papular
6%
Respiratory Tract Infection
5%
Vision Blurred
5%
Hypophosphataemia
5%
Malaise
5%
Hypercholesterolaemia
5%
Sinus Bradycardia
5%
Hyperglycaemia
5%
Hypokalaemia
5%
Rhinorrhoea
5%
Blood Lactate Dehydrogenase Increased
5%
Dysgeusia
4%
Depression
4%
Gamma-Glutamyltransferase Increased
4%
Neoplasm Progression
4%
Influenza Like Illness
4%
Peripheral Swelling
4%
Taste Disorder
2%
Hypocalcaemia
2%
Pleural Effusion
2%
Hypotension
2%
Neutrophil Count Decreased
2%
Pulmonary Embolism
2%
Interstitial Lung Disease
2%
Hypoaesthesia
2%
Oesophageal Obstruction
1%
Hypoalbuminaemia
1%
Acute Kidney Injury
1%
Appendicitis
1%
Hepatocellular Injury
1%
Pneumonitis
1%
Acute Myocardial Infarction
1%
Vocal Cord Paralysis
1%
Toxicity To Various Agents
1%
Gout
1%
C-Reactive Protein Increased
1%
Hypoglycaemia
1%
Cancer Pain
1%
Muscular Weakness
1%
Dysphagia
1%
Gastrooesophageal Reflux Disease
1%
Transaminases Abnormal
1%
Femoral Neck Fracture
1%
Hyperkalaemia
1%
Pericardial Effusion
1%
Confusional State
1%
Multiple Organ Dysfunction Syndrome
1%
Ovarian Cancer Stage I
1%
Delirium
1%
Visual Impairment
1%
Gastric Haemorrhage
1%
Seizure
1%
Fall
1%
Ligament Rupture
1%
Photopsia
1%
Malignant Pleural Effusion
1%
Viral Infection
1%
Lower Respiratory Tract Infection
1%
Diffuse Large B-Cell Lymphoma
1%
Gastroenteritis
1%
Lung Adenocarcinoma
1%
Neutropenia
1%
Partial Seizures
1%
Cognitive Disorder
1%
Peripheral Sensory Neuropathy
1%
Invasive Breast Carcinoma
1%
Lung Neoplasm Malignant
1%
Memory Impairment
1%
Cardiac Tamponade
1%
Disseminated Intravascular Coagulation
1%
Syncope
1%
Pulmonary Oedema
1%
Metastases To Meninges
1%
Metastases To Central Nervous System
1%
Balance Disorder
1%
Squamous Cell Carcinoma Of Skin
1%
Cerebrovascular Accident
1%
Encephalopathy
1%
Pneumothorax
1%
Dysarthria
1%
Neutropenic Colitis
1%
Respiratory Distress
1%
Atrial Fibrillation
1%
Pneumonia Aspiration
1%
Cholecystitis
1%
Arrhythmia
1%
Angina Pectoris
1%
Inguinal Hernia
1%
Bile Duct Stone
1%
Cholestasis
1%
Mucosal Inflammation
1%
Sudden Death
1%
Aphasia
0%
Blood Insulin Increased
0%
Depressed Level Of Consciousness
0%
Tibia Fracture
0%
Intraventricular Haemorrhage
0%
Drug-Induced Liver Injury
0%
Palpitations
0%
Respiratory Arrest
0%
Deep Vein Thrombosis
0%
Cardiac Failure
0%
Covid-19
0%
Gastroenteritis Viral
0%
Prostate Cancer
0%
Intestinal Obstruction
0%
Atypical Pneumonia
0%
Herpes Zoster
0%
Respiratory Failure
0%
Intracranial Tumour Haemorrhage
0%
Amylase Increased
0%
Ascites
0%
Brain Herniation
0%
Abdominal Pain Lower
0%
Large Intestine Perforation
0%
Bone Pain
0%
Urinary Retention
0%
Oesophagitis Ulcerative
0%
Rotator Cuff Syndrome
0%
General Physical Health Deterioration
0%
Disorientation
0%
Salmonella Sepsis
0%
Cytomegalovirus Oesophagitis
0%
Cellulitis
0%
Listeriosis
0%
Pleural Infection
0%
Vertigo Positional
0%
Septic Shock
0%
Sinusitis Fungal
0%
Tumour Haemorrhage
0%
Hodgkins Disease
0%
Ischaemic Stroke
0%
Anaemia Macrocytic
0%
Central Nervous System Lesion
0%
Acute Respiratory Failure
0%
Myocardial Infarction
0%
Arthritis
0%
Menorrhagia
0%
Platelet Count Decreased
0%
Spinal Fracture
0%
Haematuria
0%
Hemiparesis
0%
Generalised Tonic-Clonic Seizure
0%
Performance Status Decreased
0%
Pyelonephritis Acute
0%
Anxiety
0%
Haemoptysis
0%
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:View All
Provision to sign and date the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Ability to take and retain oral medications.
Age ≥18 years.
Patients with ALK+ lung cancer with evidence of ≥1 previously untreated brain metastases on brain MRI. Prior therapy (radiation or surgery) for brain metastases is allowed. However, patients must have ≥1 previously untreated at the time of enrollment.
Patients may be ALK TKI naïve OR have had prior crizotinib therapy.
Patients may be included if they are asymptomatic from their brain metastases (RTOG/EORTC grade 0) or if they have mild symptoms from their brain metastases not to exceed RTOG/ EORTC grade 1 or 2 (Grade 1: Fully functional status (i.e. able to work) with minor neurological findings, no medication needed; Grade 2: Neurological findings present sufficient to require home care / nursing assistance may be required / medications including steroids/anti-seizure agents may be required) (Cox, James D., et al "Toxicity criteria of the radiation therapy oncology group (RTOG) and the European organization for research and treatment of cancer (EORTC)." International Journal of Radiation Oncology• Biology• Physics 31.5 (1995): 1341-1346).
Neurologically symptomatic patients must not require immediate surgical or radiation therapy for their symptoms, as decided by an investigator.
Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Have adequate organ function, as determined by
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Approximate Timelines
Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like
Measurement Requirements
This trial is evaluating whether Brigatinib will improve 1 primary outcome, 9 secondary outcomes, and 2 other outcomes in patients with Brain Cancer. Measurement will happen over the course of 13-week MRI ±7 days.
Disease Control Rate (DCR) of brain metastases at 3 months
13-WEEK MRI ±7 DAYS13-WEEK MRI ±7 DAYS
DCR is defined as complete response (CR), partial response (PR), or stable disease (SD) as defined by the RANO-BM (Response Assessment in Neuro-Oncology Criteria - Brain Metastases) criteria.Analysis of blood at baseline and at progression to correlate with clinical outcomes.
UP TO 24 MONTHSUP TO 24 MONTHS
Evaluation of cfDNA at baseline and progression to correlate with clinical outcomes including incidence of disease recurrence per RANO-BM and RECIST 1.1, survival status by percentage of patients alive at 2 years, and patient rating of quality of life per EORTC QLQ-BN20 and EORTC QLQ-C30 questionnaires.To characterize corticosteroid administration before and after brigatinib initiation
UP TO 24 MONTHSUP TO 24 MONTHS
Quantification of the agent and dosage of corticosteroids at each study assessmentTime until progression with brigatinib alone (part 4)
UP TO 24 MONTHSUP TO 24 MONTHS
Time until progression at any site using RANO-BM for intracranial disease and RECIST for extracranial disease and rates at follow up intervalsBrain metastases-specific mortality
UP TO 24 MONTHSUP TO 24 MONTHS
Defined as time to intracranial progression as a component of cause of death and rates at follow up intervalsOverall survival with a strategy of brigatinib alone
UP TO 24 MONTHSUP TO 24 MONTHS
Time until death from any cause and rates at follow up intervalsPatient Q & A Section
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are common treatments for brain cancer?
Treatment of brain tumours depends on the exact location of the tumour. Radiotherapy is used in the presence of anaplastic and glioblastoma tumours. Surgery may be needed to remove the tumour when needed.
Anonymous Patient Answer
What are the signs of brain cancer?
This article summarizes the key signs and symptoms of a brain tumour, and concludes that the major signs and symptoms are seizures, headache, and a sudden worsening of condition.
Anonymous Patient Answer
Can brain cancer be cured?
Cure of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) depends on diagnosis and treatment of primary cancer, metastatic burden, and treatment of metastases prior to referral for brain cancer evaluation.
Anonymous Patient Answer
What is brain cancer?
We summarize recent updates that have changed our understanding of brain tumors and their treatment. Also, we discuss how we may improve our detection of brain cancers and what we can do to stop and decrease these diseases. Our goal is that in the future everyone we follow will have a better understanding of the changes that occur when a brain tumor appears.
Anonymous Patient Answer
How many people get brain cancer a year in the United States?
Overall, around 2.8 million people in the United States are hospitalized for brain cancer or die from brain cancer each year. This is around one fifth of all brain cancer diagnoses. Around half of those patients die within two years of being diagnosed.
Anonymous Patient Answer
What causes brain cancer?
These data suggest the importance of the brain as a target organ for systemic (blood-borne) oncogenesis and the association of specific neuropathologies with brain tumors. A better understanding of the molecular mechanisms and cellular signatures of brain tumors may help to identify novel diagnostic and potentially novel therapeutical targets.
Anonymous Patient Answer
What is the primary cause of brain cancer?
Findings from a recent study support the hypothesis that brain tumorigenesis has complex genetic, infectious, and environmental triggers. Most cases of brain cancer appear to be related to age and lifestyle.
Anonymous Patient Answer
Has brigatinib proven to be more effective than a placebo?
brigatinib showed positive benefit compared to a placebo on both progression-free and OS in patients with advanced renal cell cancers (RCCs) who received prior treatment with systemic therapy.
Anonymous Patient Answer
Who should consider clinical trials for brain cancer?
The neurologist and other health professionals will continue to see brain tumor patients in whom clinical trials could improve outcomes. Clinical trials should be offered to patients, if they agree to their patients' risk-benefit analysis
Anonymous Patient Answer
Does brigatinib improve quality of life for those with brain cancer?
Although patients with symptomatic brain tumors showed a decrease in neurological function (e.g., impaired ability to walk and think, dizziness and balance problems) when treated with brigatinib (median, 19 days), the improvement of quality of life was found to be clinically important. Although no differences in survival were found (median, 25 days), the results showed that brigatinib is highly beneficial for treating many types of primary brain tumors and is especially notable for its improved quality of life in patients with brain tumors.
Anonymous Patient Answer
Is brigatinib safe for people?
Brigatinib is a substrate for cytochrome P450 enzymes CYP3A4 and/or CYP2B6 in vivo and in vitro. Therefore, coadministration of brigatinib with medications which are substrates for CYP3A4 or CYP2B6 could increase brigatinib exposure and potentially increase its antitumor activity. However, due to this interaction effect, concurrent consumption of darunavir/ritonavir, ciprofloxacin/pyridoxine, and rifampin/methadone must be increased in adults in order to avoid a potential increase in brigatinib exposure.
Anonymous Patient Answer
Have there been other clinical trials involving brigatinib?
Brigatinib is the most advanced drug discovered in clinical trials for ALK-positive brain cancer, and further clinical research is warranted in the ALK-positive lung, colon and breast cancers as well.
Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Brain Cancer by sharing your contact details with the study coordinator.