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CDK4/6 Inhibitor

Palbociclib for Cancer

Phase 2
Waitlist Available
Led By Amy S Clark
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
Patients must have amplification of CCND1, 2, or 3, or another aberration, as determined via the MATCH Master Protocol
Must not have
Patients with known or symptoms of left ventricular dysfunction will be excluded
Patients must not have breast cancer, mantle cell lymphoma or myeloma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights
No Placebo-Only Group

Summary

This trial tests palbociclib, a medication taken by mouth, in patients with advanced cancers that have specific genetic changes. It works by blocking proteins needed for cancer cell growth. Researchers hope it will shrink the cancer or stop it from growing.

Who is the study for?
This trial is for patients with cancers that have specific genetic changes called CCND1, 2, or 3 amplification. They must not have breast cancer, mantle cell lymphoma or myeloma and should not be on certain drugs affecting heart rhythm. Prior treatment with CDK4/6 inhibitors disqualifies them.
What is being tested?
The trial tests Palbociclib's effectiveness in stopping the growth of cancers with CCND1, 2, or 3 amplifications by blocking proteins CDK4 and CDK6. It's a phase II study to see if this drug can shrink these types of cancers or halt their progression.
What are the potential side effects?
Palbociclib may cause side effects like low white blood cell counts (which can lead to increased infection risk), fatigue, nausea, hair thinning or loss, nosebleeds, mouth sores and diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My recent ECG showed no significant heart issues.
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My cancer has a specific genetic change related to CCND1, 2, or 3.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have heart issues related to the left ventricle.
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I do not have breast cancer, mantle cell lymphoma, or myeloma.
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I am not taking any strong medications or eating foods that affect certain liver enzymes.
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I am not allergic to palbociclib or similar drugs.
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I have not been treated with CDK4/6 inhibitors like palbociclib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
6-month Progression-free Survival (PFS) Rate
Progression Free Survival (PFS)

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Headache
17%
Mucositis
17%
Diarrhea
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Obesity
10%
Flu like symptoms
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Bone pain
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
7%
Pruritus
5%
Pain
5%
Dysgeusia
3%
Abdominal pain
3%
Respiratory infection
3%
Nail disorder
1%
Spinal cord compression
1%
Heart failure
1%
Cholecystitis acute
1%
Pleural effusion
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Dislocation of hip
1%
Renal failure
1%
Bronchial infection
1%
Urinary tract infection
1%
Thromboembolic event
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
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: Treatment (palbociclib)Experimental Treatment1 Intervention
Patients receive palbociclib PO QD days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3790

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
CDK4/6 inhibitors, such as Palbociclib, function by blocking cyclin-dependent kinases 4 and 6, essential for cell cycle progression from the G1 to S phase, thereby preventing cancer cell proliferation. This targeted approach is crucial for cancer patients as it specifically disrupts the growth of cancer cells while minimizing damage to normal cells. Other common treatments include chemotherapy, which targets rapidly dividing cells, and immunotherapy, which boosts the immune system's ability to fight cancer. These mechanisms are vital as they provide multiple strategies to control and potentially eradicate cancer, improving patient outcomes and survival rates.
The role of abemaciclib in treatment of advanced breast cancer.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,130 Total Patients Enrolled
Amy S ClarkPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Palbociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439201 — Phase 2
Cancer Research Study Groups: Treatment (palbociclib)
Cancer Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT04439201 — Phase 2
Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439201 — Phase 2
~4 spots leftby Dec 2025