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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit rate estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment
Side effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850763%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Diarrhea
17%
Headache
17%
Mucositis
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Flu like symptoms
10%
Obesity
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Pruritus
7%
Bone pain
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
5%
Dysgeusia
5%
Pain
3%
Nail disorder
3%
Respiratory infection
3%
Abdominal pain
1%
Osteonecrosis of jaw
1%
Spinal cord compression
1%
Heart failure
1%
Bronchial infection
1%
Pleural effusion
1%
Ascites
1%
Urinary tract infection
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Renal failure
1%
Dislocation of hip
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Thromboembolic event
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~3790
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,264 Total Patients Enrolled
42 Trials studying Prostate Cancer
12,820 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,848 Total Patients Enrolled
9 Trials studying Prostate Cancer
6,884 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.
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