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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
Must not have
Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry
Child's-Pugh Class C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization through study completion, assessed up to 100 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.
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.
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 below
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 or older with liver cancer that hasn't responded to treatment.
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I am not pregnant or breastfeeding.
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My liver function is mildly to moderately impaired.
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My tumor biopsy shows positive for RB-function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery or a significant injury in the last 4 weeks.
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My liver disease is severe.
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I haven't had serious heart problems like heart failure, heart attack, or uncontrolled high blood pressure in the last year.
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I have been diagnosed with HIV.
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My tumor biopsy shows no RB protein activity.
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I am on dialysis for kidney failure.
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I do not have any uncontrolled infections or unstable health conditions.
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I cannot swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization through study completion, assessed up to 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization through study completion, assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Disease Progression
Secondary study objectives
Number of Adverse Events
Overall Survival (OS)
Response Rate (RR)

Side effects data

From 2023 Phase 3 trial • 666 Patients • NCT01740427
69%
Neutropenia
42%
Arthralgia
41%
Fatigue
38%
Nausea
34%
Alopecia
31%
Diarrhoea
29%
Cough
28%
Anaemia
26%
Leukopenia
26%
Back pain
25%
Headache
24%
Constipation
24%
Neutrophil count decreased
23%
Hot flush
22%
Pain in extremity
21%
Nasopharyngitis
19%
Decreased appetite
19%
White blood cell count decreased
19%
Asthenia
18%
Dyspnoea
18%
Vomiting
18%
Dizziness
18%
Rash
17%
Upper respiratory tract infection
17%
Stomatitis
16%
Insomnia
16%
Urinary tract infection
15%
Oedema peripheral
15%
Abdominal pain
15%
Alanine aminotransferase increased
15%
Myalgia
15%
Dry skin
14%
Pyrexia
14%
Fall
14%
Aspartate aminotransferase increased
14%
Thrombocytopenia
12%
Dyspepsia
11%
Oropharyngeal pain
11%
Mucosal inflammation
11%
Pruritus
10%
Epistaxis
10%
Pain
10%
Bone pain
10%
Muscle spasms
10%
Anxiety
10%
Hypertension
9%
Abdominal pain upper
9%
Platelet count decreased
9%
Depression
8%
Influenza like illness
8%
Musculoskeletal pain
8%
Gastrooesophageal reflux disease
8%
Musculoskeletal chest pain
8%
Dysgeusia
7%
Sinusitis
7%
Oral herpes
7%
Chest pain
7%
Blood creatinine increased
7%
Weight decreased
7%
Lacrimation increased
6%
Bronchitis
6%
Hypokalaemia
6%
Paraesthesia
6%
Dry mouth
6%
Neck pain
6%
Cataract
6%
Dry eye
5%
Nasal congestion
5%
Breast pain
5%
Contusion
5%
Vision blurred
5%
Toothache
5%
Influenza
5%
Rhinitis
5%
Chills
5%
Abdominal distension
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

Awards & Highlights

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.

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
163 Previous Clinical Trials
10,822 Total Patients Enrolled
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,717,158 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

PD-0332991 (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01356628 — Phase 2
Liver Cancer Research Study Groups: PD-0332991
Liver Cancer Clinical Trial 2023: PD-0332991 Highlights & Side Effects. Trial Name: NCT01356628 — Phase 2
PD-0332991 (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01356628 — Phase 2
~2 spots leftby Dec 2025
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