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CDK4/6 Inhibitor
Palbociclib for Brain Metastasis
Phase 2
Recruiting
Led By Priscilla Brastianos, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm
Participants must have histologically or cytologically confirmed disease from any solid tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up registration to death due to any cause, or censored at date last known alive. patients will be followed for a maximum of 2 years after end-of-treatment visit.
Awards & highlights
Study Summary
This trial is looking at whether the drug palbociclib can help treat brain cancer that has come back.
Who is the study for?
This trial is for adults over 18 with recurrent brain metastases from any solid tumor. They must have measurable disease in the CNS, stable corticosteroids use, and normal organ/marrow function. Excluded are those on other investigational drugs, with uncontrolled illnesses, pregnant/breastfeeding women, prior CDK4/6 inhibitor treatment, recent chemotherapy/immunotherapy/radiotherapy or taking drugs affecting CYP3A enzymes.Check my eligibility
What is being tested?
The study tests palbociclib as a potential treatment for progressive brain metastases. It's supported by Pfizer and includes participants who've shown alterations in the CDK pathway. The drug's effectiveness will be measured against specific criteria for CNS lesion progression.See study design
What are the potential side effects?
Palbociclib may cause side effects like low blood cell counts leading to increased infection risk or bleeding problems; fatigue; nausea; hair thinning; rash; diarrhea and mouth sores. Some patients might experience abnormal liver test results.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a brain lesion that is at least 10 mm big.
Select...
My cancer diagnosis was confirmed through tissue or cell analysis.
Select...
I can care for myself but may not be able to do active work.
Select...
I have had a brain surgery or biopsy for genetic testing.
Select...
My brain cancer is getting worse despite previous treatments.
Select...
My cancer has a CDK pathway mutation.
Select...
I am 18 years old or older.
Select...
My blood tests for organ and bone marrow function are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from registration to the earlier of progression or death due to any cause. patients will be followed for a maximum of 2 years after end-of-treatment visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from registration to the earlier of progression or death due to any cause. patients will be followed for a maximum of 2 years after end-of-treatment visit.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Benefit Rate (Intracranial)
Secondary outcome measures
Clinical Benefit Rate (Extracranial)
Extracranial disease progression rate
Intracranial disease progression rate
+2 moreSide effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Hyponatremia
35%
Arthralgia
35%
Cough
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Peripheral sensory neuropathy
17%
Upper respiratory infection
17%
Sinusitis
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Hypophosphatemia
9%
Epistaxis
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Skin infection
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cellulitis
6%
Knee pain
6%
Death
6%
Cataract
6%
Dehydration
6%
Itchy skin
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Back spasms
4%
Burn
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Watering eyes
4%
Edema trunk
4%
Dry eye
4%
Head injury
4%
Skin bump
4%
Sinus pain
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Memory impairment
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Intrascapular pain
2%
Paronychia
2%
Puncture wound
2%
Urine discoloration
2%
Pharyngitis
2%
Sinus tachycardia
2%
Vaginal discharge
2%
Hemorrhoids
2%
Leg pain
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
2%
Hypermagnesemia
2%
Erythema multiforme
2%
Erythema right breast
2%
Vaginal infection
2%
Sinus congestion
2%
Localized edema
2%
Yeast infection
2%
Diverticulitis
2%
Sepsis
2%
Photophobia
2%
Blood bilirubin increased
2%
Facial nerve disorder
2%
Paresthesia
2%
Urinary retention
2%
Agitation
2%
Oral fissure
2%
Eye lid pain
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
COPD
2%
Nail loss
2%
Fracture
2%
Fever blister
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Vaginal itching
2%
Lung cancer
2%
Hyperuricemia
2%
Bilateral nares sores
2%
Shoulder nodule
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Cold sweats
2%
Radiation recall reaction (dermatologic)
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant
Trial Design
1Treatment groups
Experimental Treatment
Group I: PalbociclibExperimental Treatment1 Intervention
Description Patients who fulfill eligibility criteria will be entered into the trial to receive Palbociclib
After the screening procedures confirm participation in the research study:
Palbociclib- Fixed Dose, daily for 21 days per cycle.
The participant will be requested to maintain a medication diary of each dose of medication. The medication diary will be returned to clinic staff at the end of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,941 Previous Clinical Trials
13,200,638 Total Patients Enrolled
PfizerIndustry Sponsor
4,578 Previous Clinical Trials
10,923,447 Total Patients Enrolled
Priscilla Brastianos, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
6 Previous Clinical Trials
475 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a CDK4/6 inhibitor before.I have stable levels of body salts and minerals.I am currently taking medication that can affect my heart's rhythm.I have a brain lesion that is at least 10 mm big.I have recently undergone chemotherapy, immunotherapy, or radiotherapy.I have a heart condition related to abnormal heart rhythms.My cancer diagnosis was confirmed through tissue or cell analysis.I can care for myself but may not be able to do active work.I have had a brain surgery or biopsy for genetic testing.My brain cancer is getting worse despite previous treatments.My cancer has a CDK pathway mutation.I have been on a steady dose of corticosteroids for at least a week.I am HIV-positive and on combination antiretroviral therapy.My cancer outside the brain is getting worse but I can still participate.I am taking medication that affects liver enzymes.I am 18 years old or older.I am not currently on any other cancer treatments.I do not have any uncontrolled illnesses.My blood tests for organ and bone marrow function are normal.My cancer has spread to the lining of my brain and spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Palbociclib
Awards:
This trial has 3 awards, including:- 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.
- 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.
To what extent can Palbociclib help patients with ____ cancer?
"Palbociclib is effective in the treatment of breast, malignant neoplasms, and postmenopausal patients."
Answered by AI
Does Palbociclib have a high potential for patient harm?
"Given that this is a phase 2 trial, meaning there is only some data supporting safety and none yet for efficacy, our team has estimated the safety of Palbociclib to be a 2."
Answered by AI
Are there any other completed or ongoing studies of Palbociclib's effects?
"As of right now, 139 separate clinical trials are ongoing for Palbociclib. Of those, 17 are in their third and final Phase. Most of the research being conducted on Palbociclib is based out of Burgas, New jersey; however 6640 different medical facilities worldwide are running similar studies."
Answered by AI
Are patients still being enrolled in this research project?
"Indeed, this clinical trial is still recruiting patients as per the information on clinicaltrials.gov. 30 individuals are needed for the study which began on November 1st, 2016 and was most recently updated on October 25th, 2021. The recruitment process will take place at 2 different sites."
Answered by AI
To date, how many people have signed up for this clinical trial?
"That is correct, the listing on clinicaltrials.gov does show that this research project requires new participants. The study was first advertised on November 1st, 2016 and updated most recently on October 25th, 2021. There are 30 positions available at 2 different locations."
Answered by AI
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