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CDK4/6 Inhibitor
Palbociclib for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial is testing a new drug, palbociclib, for prostate cancer. They will look at side effects and if it can help predict which patients the drug will work best for.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They need rising PSA levels, ongoing hormone treatment, and no small cell/neuroendocrine differentiation in their cancer. Major organs must function well, they should have a life expectancy of at least 6 months, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing palbociclib's effects on metastatic castration-resistant prostate cancer. It will assess how the drug impacts the disease and examine side effects while also looking for markers predicting who might benefit most from this treatment.See study design
What are the potential side effects?
Palbociclib may cause low white blood cell counts which increases infection risk, fatigue, nausea or vomiting, hair thinning or loss, diarrhea or constipation, mouth sores and potential liver issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
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 estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment
Secondary outcome measures
Effect of Palbociclib on PSA decline based on decrease in PSA test values from the baseline value
Number and severity of adverse events
Objective response determined by RECIST 1.1
+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%
Cough
35%
Arthralgia
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%
Sinusitis
17%
Upper respiratory infection
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Tooth infection
7%
Non-cardiac chest pain
7%
Skin infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Death
6%
Cellulitis
6%
Cataract
6%
Itchy skin
6%
Dehydration
6%
Knee pain
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%
Vaginal dryness
4%
Watering eyes
4%
Burn
4%
Flu-like symptoms
4%
Edema trunk
4%
Dry eye
4%
Sinus pain
4%
Head injury
4%
Memory impairment
4%
Skin bump
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
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%
Bilateral nares sores
2%
Localized edema
2%
Wrist fracture
2%
Lung cancer
2%
Vaginal discharge
2%
Erythema multiforme
2%
Erythema right breast
2%
Cold sweats
2%
Puncture wound
2%
Activated partial thromboplastin time prolonged
2%
Paronychia
2%
Vaginal infection
2%
COPD
2%
Sinus congestion
2%
Sinus tachycardia
2%
Diverticulitis
2%
Sepsis
2%
Hyperuricemia
2%
Facial nerve disorder
2%
Paresthesia
2%
Agitation
2%
Urinary retention
2%
Oral fissure
2%
Eye lid pain
2%
Pharyngitis
2%
Blood bilirubin increased
2%
Flank pain
2%
Cognitive disturbance
2%
Radiation recall reaction (dermatologic)
2%
Photophobia
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
Fracture
2%
Vaginal itching
2%
Fever blister
2%
Hemorrhoids
2%
Yeast infection
2%
Intrascapular pain
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Leg pain
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Hypermagnesemia
2%
Urine discoloration
2%
Nail loss
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%
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
125mg orally days 1-21 every 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,568 Previous Clinical Trials
10,911,867 Total Patients Enrolled
41 Trials studying Prostate Cancer
12,350 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,434 Total Patients Enrolled
10 Trials studying Prostate Cancer
7,116 Patients Enrolled for Prostate Cancer
Kim ChiStudy ChairBCCA - Vancouver Cancer Centre, BC Canada
4 Previous Clinical Trials
491 Total Patients Enrolled
3 Trials studying Prostate Cancer
468 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to palbociclib or its ingredients.I do not have an infection that needs treatment with medication.I do not have severe heart problems.I have had cancer before, but it was either skin cancer treated well or any cancer treated over 5 years ago with no signs of return.I have had brain involvement but am stable 4 weeks after treatment without needing steroids or certain seizure meds.I do not have HIV.I stopped taking strong medication that affects liver enzymes 7 days ago.I am taking bisphosphonates or denosumab for reasons other than high calcium, bone loss, or bone events.I am not taking any cancer treatments except for LHRH.This criterion seems incomplete. Please provide more details.I am mostly active and my doctor expects me to live 6 months or more.I am 18 years old or older.My PSA levels have increased at least twice over a week apart.I am eligible for or have had surgery.I haven't had certain radiation treatments recently or ever had strontium-89.I have agreed to provide a sample of my tumor for research.I have had surgery to remove one or both of my testicles.My cancer has spread to soft tissues or internal organs.I have previously received treatments like immune checkpoint inhibitors or vaccines for my condition.I had major surgery over 2 weeks ago or minor surgery over a week ago, and my wounds have healed.I am currently receiving or have received radiation therapy.I need more details to provide a summary.I am on LHRH therapy with testosterone levels below 50 ng/dL.I have recovered from serious side effects of previous treatments.I am currently undergoing or have completed hormonal therapy.I have not undergone cytotoxic therapy.I am currently not on any other therapy.I have previously been treated with targeted cancer therapies.I am taking less than 10 mg of prednisone daily or using steroids topically/inhaled.My kidney function is within the normal range.I am a man who can father children and will use effective birth control during and for 3 months after treatment.I have undergone surgical or medical castration.I have recovered from side effects of previous treatments and waited the required time before joining.I can swallow pills and don't have major stomach or bowel issues affecting drug absorption.I am taking more than 10 mg of prednisone daily, but I can use topical, inhaled, or local corticosteroids.My prostate cancer is confirmed and not linked to small cell/neuroendocrine features.My cancer has worsened after treatment to lower hormones.I have not taken any experimental drugs in the last 30 days or 5 half-lives, whichever is longer.I have previously been treated with specific hormone therapies for my cancer.I am not on Warfarin or similar blood thinners, but I may be on heparin or LMWH.I have never been treated with CDK or mTOR inhibitors.My treatment follows the standard schedule.I have not been treated with CDK4/6, mTOR inhibitors, or strontium-89.I am receiving or have received systemic therapy.I have had docetaxel or up to one other chemotherapy for prostate cancer.I am currently receiving or have received immunotherapy.I am taking medication for bone health or high calcium levels.
Research Study Groups:
This trial has the following groups:- Group 1: Palbociclib
Awards:
This trial has 1 awards, including:- 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.
How many medical institutions are contributing to this research endeavor?
"Ottawa Hospital Research Institute, Saskatoon Cancer Centre, The Jewish General Hospital and 12 other medical institutions are playing host to this clinical trial. Ottawa is situated in Ontario while Quebec and Alberta houses the latter two locations respectively."
Answered by AI
Has Palbociclib been officially sanctioned by the FDA?
"While clinical trials for Palbociclib are still in the second phase, there is sufficient evidence indicating that this medication has a degree of safety. Thus, we have rated it at 2 on our scale from 1 to 3."
Answered by AI
Are there any other research projects involving Palbociclib that have been conducted?
"In 2012, Palbociclib was first investigated at Unimed Medical Institute. 75 studies have since been completed and 133 are presently enrolling patients, predominantly from the Ottawa region in Canada."
Answered by AI
Are there still opportunities to join this clinical trial?
"According to the clinicaltrials.gov database, this particular investigation is no longer accepting patient applications. Initially posted on February 9th 2017 and last updated on September 26th 2022, it has been superseded by 1451 other studies currently recruiting volunteers."
Answered by AI
What is the scale of this clinical trial in terms of participant numbers?
"This trial is no longer open for recruitment, as it was initially published on February 9th 2017 and last modified September 26th 2022. Fortunately, there are many other trials recruiting - 1318 related to prostate cancer and 133 regarding Palbociclib specifically."
Answered by AI
What medical conditions have been managed effectively with Palbociclib?
"Palbociclib has been approved for use in treating postmenopausal women with breast cancer and other malignant neoplasms."
Answered by AI
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