What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for cancer, particularly those involving CDK4/6 inhibitors like Palbociclib, often result in side effects such as neutropenia (low white blood cell count), anemia, fatigue, nausea, and diarrhea. Other targeted therapies and chemotherapies may also cause neuropathy, thrombocytopenia (low platelet count), and gastrointestinal issues. Additionally, some treatments can lead to specific toxicities like hypocalcemia, hypokalemia, and increased liver enzymes. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Palbociclib is a CDK4/6 inhibitor that has been approved by the FDA for the treatment of certain types of cancer, particularly hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Other similar CDK4/6 inhibitors that have received FDA approval include ribociclib and abemaciclib. These drugs work by inhibiting the activity of cyclin-dependent kinases 4 and 6, which are crucial for cell cycle progression and cancer cell proliferation. Their approval has provided new therapeutic options for patients with specific cancer subtypes, improving outcomes and offering alternatives to traditional chemotherapy.

What other types of research exist?

Promising alternatives to Palbociclib for cancer treatment in 2024 include: 1) Infigratinib and Futibatinib, which are FGFR inhibitors showing efficacy in cholangiocarcinoma with FGFR2 fusions/rearrangements. 2) Pembrolizumab and Nivolumab, immune checkpoint inhibitors that have demonstrated significant benefits in various cancers, including melanoma. 3) Acalabrutinib and Zanubrutinib, BTK inhibitors that are effective in chronic lymphocytic leukemia and mantle cell lymphoma. These therapies offer novel mechanisms of action and have shown promising results in clinical trials.

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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

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

Study Summary

This trial is testing the effects ofpalbociclib in patients with cancer that has genetic changes called CCND1, 2, or 3 amplification. Palbociclib may stop the growth of cancer cells by blocking proteins called CDK4 and CDK6.

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.Check my eligibility

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.See study design

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

Select...

My recent ECG showed no significant heart issues.

Select...

My cancer has a specific genetic change related to CCND1, 2, or 3.

Timeline

Screening ~ 3 weeks3 visits

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

6-month Progression-free Survival (PFS) Rate

Progression Free Survival (PFS)

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979

96%

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%

Arthralgia

35%

Cough

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%

Upper respiratory infection

17%

Sinusitis

17%

Fever

17%

Anxiety

17%

Sore throat

15%

Hypoalbuminemia

13%

Urinary tract infection

13%

Hyperhidrosis

13%

Bone pain

13%

Nasal congestion

13%

Dry skin

11%

Hypernatremia

11%

Allergic rhinitis

11%

Weight loss

Hypophosphatemia

Epistaxis

COVID-19

Dysphagia

Blurred vision

Skin infection

Non-cardiac chest pain

Tooth infection

Vertigo

Breast pain

Bronchitis

Postnasal drip

Common cold

Neck pain

Lymphedema

Cellulitis

Knee pain

Death

Cataract

Dehydration

Itchy skin

Psoriasis

Body aches

Buttock pain

Lung infection

Allergic reaction

Hypoglycemia

Urinary frequency

Osteopenia

Rash acneiform

Gout

Bug bite

Arthritis

Thromboembolic event

Back spasms

Burn

Vaginal dryness

Flu-like symptoms

Watering eyes

Edema trunk

Dry eye

Head injury

Skin bump

Sinus pain

Right arm numbness

Nodule

Hip pain

Peripheral motor neuropathy

Memory impairment

Hypothyroidism

Broken tooth

Abdominal pain

Dry lips

Toothache

Tick bite

Extremity infection

Hypomagnesemia

Generalized muscle weakness

Pleural effusion

Sleep apnea

Right thumb bump

Osteonecrosis of jaw

Chest pain - cardiac

Acute kidney injury

Muscle cramp

Muscle spasm

Gastroesophageal reflux disease

Bruising

Burn - left hand

Brittle nail

Intrascapular pain

Paronychia

Puncture wound

Pharyngitis

Sinus tachycardia

Bladder infection

Urine discoloration

Hemorrhoids

Leg pain

Wrist fracture

Hypermagnesemia

Erythema multiforme

Erythema right breast

Laryngeal inflammation

Vaginal infection

Sinus congestion

Localized edema

Yeast infection

Facial nerve disorder

Vaginal discharge

Diverticulitis

Sepsis

Photophobia

Blood bilirubin increased

Paresthesia

Urinary retention

Agitation

Oral fissure

Eye lid pain

Flank pain

Cognitive disturbance

Generalized weakness

Rhinovirus

Wound infection

COPD

Nail loss

Fever blister

Wrist pain

Hoarseness

Fungal toe infection

Respiratory syncytial virus (RSV)

Fracture

Activated partial thromboplastin time prolonged

Vaginal itching

Lung cancer

Hyperuricemia

Bilateral nares sores

Shoulder nodule

Peeling lips

Vaginal itch

Head injury - upper left occipital swelling

Acoustic neuroma

Eye lid pain/soreness

Open cutaneous area left breast

Peeling skin palms of hands

Mole pain

Itchy scalp

Spinal fracture

Cold sweats

Radiation recall reaction (dermatologic)

Asthma

Hand cramps

Left hand puncture wound

C. difficile

Gait disturbance

Myocardial infarction

Red eye

Groin pain

Superficial thrombophlebitis

Paronychia - infection right middle

Snake bite

Hemoglobin increased

Muscle weakness lower limb

Right arm pain

Mitral valve disease

Tinnitus

Vestibular schwannoma

Dry mouth

Oral dysesthesia

Oral pain

Stomach pain

Ulcerative colitis

Acute bronchitis

Otitis media

INR increased

Lymphocyte count increased

Bilateral leg pain

Chest wall pain

Left sided flank pain

Sternum pain

ADHD

Confusion

Sacroliac joint pain

Shoulder pain

Hallucinations

Mood swings

Nasal dryness

Productive cough

Voice alteration

Hypotension

Cold sensitivity

Sciatic pain

Nasal drainage

Heart failure

Skin bumps

Skin hypopigmentation

Leg stiffness

Asystole

Failure to thrive

Intracranial hemorrhage

Gastric ulcer

Gingival pain

Hematochezia

Hemorrhoidal hemorrhage

Dilation of appendix with periappendiceal fat stranding seen on CT

Edema face

Yeast infection under right breast

Weight gain

Spasticity

Syncope

Blister

Sores bilateral nares

Stomach rash

Tender nail bed

100%

80%

60%

40%

20%

Study treatment Arm

Palbociclib + Letrozole or + Fulvestrant

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

~3760

0 / 2Eligibility criteria met

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.