Your session is about to expire
← Back to Search
CDK4/6 Inhibitor
PD-0332991 for Liver Cancer
Phase 2
Waitlist Available
Led By Avnish Bhatia, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate bone marrow, liver and renal function as assessed by the following: A. Hemoglobin ≥ 8 g/dL B. WBC ≥ 4,000/uL C. Absolute neutrophil count ≥ 1,500/uL D. Platelets ≥ 75,000/uL E. Total bilirubin ≤ 1.5 times ULN F. ALT and AST ≤ 5 times ULN G. Creatinine ≤ 1.5 times ULN H. Albumin ≥ 2.5 mg/dL
ECOG Performance status of ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization through study completion, assessed up to 100 months
Awards & highlights
Study Summary
This trialis testing a drug to treat advanced liver cancer, stopping tumor cell growth and multiplication.
Who is the study for?
This trial is for adults with advanced liver cancer (HCC) who haven't responded to current treatments. They must have documented HCC, be in good enough health as judged by specific blood and organ function tests, and not be pregnant or breastfeeding. Contraception is required for participants of childbearing potential. Those with other active cancers or severe heart conditions are excluded.Check my eligibility
What is being tested?
The study is testing PD-0332991, a drug that aims to halt the growth of liver tumor cells by preventing DNA replication. This Phase 2 trial will assess its effectiveness in patients whose tumors can't be surgically removed and who meet certain health criteria.See study design
What are the potential side effects?
While the side effects of PD-0332991 aren't detailed here, similar drugs often cause fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 or older with liver cancer that hasn't responded to treatment.
Select...
I am not pregnant or breastfeeding.
Select...
My liver function is mildly to moderately impaired.
Select...
My tumor biopsy shows positive for RB-function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization through study completion, assessed up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization through study completion, assessed up to 100 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Disease Progression
Secondary outcome measures
Number of Adverse Events
Overall Survival (OS)
Response Rate (RR)
Side effects data
From 2023 Phase 3 trial • 666 Patients • NCT0174042769%
Neutropenia
41%
Fatigue
41%
Arthralgia
38%
Nausea
34%
Alopecia
30%
Diarrhoea
29%
Cough
27%
Anaemia
26%
Leukopenia
26%
Back pain
25%
Headache
23%
Constipation
23%
Neutrophil count decreased
23%
Hot flush
22%
Pain in extremity
21%
Nasopharyngitis
19%
Decreased appetite
19%
Asthenia
18%
Dyspnoea
18%
White blood cell count decreased
18%
Vomiting
17%
Upper respiratory tract infection
17%
Stomatitis
17%
Dizziness
17%
Rash
16%
Urinary tract infection
16%
Insomnia
15%
Abdominal pain
15%
Myalgia
15%
Dry skin
14%
Pyrexia
14%
Oedema peripheral
14%
Aspartate aminotransferase increased
14%
Alanine aminotransferase increased
14%
Thrombocytopenia
13%
Fall
12%
Dyspepsia
11%
Mucosal inflammation
11%
Oropharyngeal pain
11%
Pruritus
10%
Pain
10%
Epistaxis
10%
Bone pain
10%
Muscle spasms
10%
Anxiety
9%
Abdominal pain upper
9%
Platelet count decreased
9%
Depression
9%
Hypertension
8%
Influenza like illness
8%
Musculoskeletal pain
8%
Gastrooesophageal reflux disease
8%
Musculoskeletal chest pain
8%
Dysgeusia
7%
Sinusitis
7%
Blood creatinine increased
7%
Oral herpes
7%
Weight decreased
7%
Lacrimation increased
7%
Chest pain
6%
Bronchitis
6%
Hypokalaemia
6%
Paraesthesia
6%
Dry mouth
6%
Neck pain
6%
Cataract
6%
Dry eye
5%
Rhinitis
5%
Nasal congestion
5%
Chills
5%
Breast pain
5%
Abdominal distension
5%
Vision blurred
5%
Toothache
5%
Rhinorrhoea
2%
Febrile neutropenia
1%
Disease progression
1%
Pleural effusion
1%
Syncope
1%
Sepsis
1%
Malignant melanoma
1%
Pathological fracture
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Pneumonia
1%
Pyelonephritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib Plus Letrozole
Placebo Plus Letrozole
Trial Design
1Treatment groups
Experimental Treatment
Group I: PD-0332991Experimental Treatment1 Intervention
PD-0332991 in the Treatment in Patients with Advanced Hepatocellular Carcinoma
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?
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,888 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,851 Total Patients Enrolled
2 Trials studying Liver Cancer
317 Patients Enrolled for Liver Cancer
Avnish Bhatia, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery or a significant injury in the last 4 weeks.My liver disease is severe.I can take care of myself but might not be able to do heavy physical work.I haven't had serious heart problems like heart failure, heart attack, or uncontrolled high blood pressure in the last year.I have been diagnosed with HIV.I have not had serious stomach or intestinal bleeding in the last month.I do not have any health conditions that could make this study unsafe for me.I am 18 or older with liver cancer that hasn't responded to treatment.I am not pregnant or breastfeeding.I am using or willing to use effective birth control methods if I can have children.I haven't needed treatment for another cancer besides skin, cervical, superficial bladder cancer, or early prostate issues in the last 3 years.My liver cancer diagnosis was confirmed by MRI, biopsy, or high alpha-fetoprotein levels, and it cannot be surgically removed.My tumor biopsy shows positive for RB-function.I had cancer treatment before, but it's been at least 4 weeks since my last treatment.I had brain metastases treated over 4 weeks ago, no active brain disease now, and haven't taken steroids for a week.My liver function is mildly to moderately impaired.I do not have any active cancer needing treatment, except for minor skin cancers or cancers treated over 3 years ago.My tumor biopsy shows no RB protein activity.I am on dialysis for kidney failure.I do not have any uncontrolled infections or unstable health conditions.I cannot swallow pills.
Research Study Groups:
This trial has the following groups:- Group 1: PD-0332991
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.
Has the FDA approved PD-0332991 for use?
"The safety of PD-0332991 has been rated a 2. This is because, at this stage in the clinical trial process there is evidence to suggest that it may be safe but as yet no proof exists supporting its efficacy."
Answered by AI
What applications has PD-0332991 been explored for therapeutically?
"Commonly used to address breast cancer, PD-0332991 can also be taken as a therapeutic measure for other malignant neoplasms and postmenopausal issues, along with advance directives."
Answered by AI
Have any other research efforts focused on PD-0332991?
"Currently, there are 134 research initiatives in progress for the drug PD-0332991, with 16 of them being at Phase 3. While most studies are located near Burgas, New jersey, overall 6549 sites have been established to examine this medication's efficacy and safety."
Answered by AI
Is this the inaugural trial of its kind?
"Presently, there are 134 active trials for PD-0332991 hosted across 1320 cities and 56 nations. The first trial of this drug, sponsored by Pfizer in 2011, included 23 patients who completed the Phase 2 stage of its approval process. Since then, a further 77 studies have been successfully concluded."
Answered by AI
Are there any slots still available for participation in this trial?
"The information accessible via clinicaltrials.gov states that this experiment is not actively seeking volunteers; it was first published on May 25th 2011, and later revised on December 13th 2022. However, there are over 2900 alternative experiments which are currently recruiting participants for their trials."
Answered by AI
What is the upper limit on participants for this clinical trial?
"Unfortunately, this trial is not currently taking on recruits. This study was initially posted in May of 2011 and last edited in December 2022; if you are looking for other studies to join, there are 2785 research projects actively recruiting patients with liver cancer and 134 trials searching for participants who could benefit from PD-0332991."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger