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CDK4/6 Inhibitor

Palbociclib for Brain Metastasis

Phase 2

Recruiting

Led By Priscilla Brastianos, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm

Participants must have histologically or cytologically confirmed disease from any solid tumor

Must not have

Prior treatment with CDK4/6 inhibitor

Uncontrolled electrolyte disorders that can compound the effects of QTc-prolonging drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up registration to death due to any cause, or censored at date last known alive. patients will be followed for a maximum of 2 years after end-of-treatment visit.

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is looking at whether the drug palbociclib can help treat brain cancer that has come back.

Who is the study for?

This trial is for adults over 18 with recurrent brain metastases from any solid tumor. They must have measurable disease in the CNS, stable corticosteroids use, and normal organ/marrow function. Excluded are those on other investigational drugs, with uncontrolled illnesses, pregnant/breastfeeding women, prior CDK4/6 inhibitor treatment, recent chemotherapy/immunotherapy/radiotherapy or taking drugs affecting CYP3A enzymes.

What is being tested?

The study tests palbociclib as a potential treatment for progressive brain metastases. It's supported by Pfizer and includes participants who've shown alterations in the CDK pathway. The drug's effectiveness will be measured against specific criteria for CNS lesion progression.

What are the potential side effects?

Palbociclib may cause side effects like low blood cell counts leading to increased infection risk or bleeding problems; fatigue; nausea; hair thinning; rash; diarrhea and mouth sores. Some patients might experience abnormal liver test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a brain lesion that is at least 10 mm big.

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My cancer diagnosis was confirmed through tissue or cell analysis.

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I can care for myself but may not be able to do active work.

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I have had a brain surgery or biopsy for genetic testing.

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My brain cancer is getting worse despite previous treatments.

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My cancer has a CDK pathway mutation.

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I am 18 years old or older.

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My blood tests for organ and bone marrow function are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a CDK4/6 inhibitor before.

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I have stable levels of body salts and minerals.

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I am currently taking medication that can affect my heart's rhythm.

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I have recently undergone chemotherapy, immunotherapy, or radiotherapy.

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I have a heart condition related to abnormal heart rhythms.

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I am HIV-positive and on combination antiretroviral therapy.

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I am taking medication that affects liver enzymes.

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I am not currently on any other cancer treatments.

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I do not have any uncontrolled illnesses.

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My cancer has spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ registration to death due to any cause, or censored at date last known alive. patients will be followed for a maximum of 2 years after end-of-treatment visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~registration to death due to any cause, or censored at date last known alive. patients will be followed for a maximum of 2 years after end-of-treatment visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and registration to death due to any cause, or censored at date last known alive. patients will be followed for a maximum of 2 years after end-of-treatment visit. for reporting.

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 (Intracranial)

Secondary study objectives

Clinical Benefit Rate (Extracranial)

Overall Survival Rate

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%

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%

Obesity

10%

Flu like symptoms

Pain in extremity

Constipation

Fever

Pruritus

Bone pain

Dizziness

Dyspepsia

Hot flashes

Pain

Dysgeusia

Respiratory infection

Abdominal pain

Nail disorder

Spinal cord compression

Heart failure

Pleural effusion

Ascites

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Dislocation of hip

Bronchial infection

Urinary tract infection

Thromboembolic event

Osteonecrosis of jaw

Palmar-plantar erythrodysesthesia syndrome

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

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: PalbociclibExperimental Treatment1 Intervention

Description Patients who fulfill eligibility criteria will be entered into the trial to receive Palbociclib After the screening procedures confirm participation in the research study: * Palbociclib- Fixed Dose, daily for 21 days per cycle. * The participant will be requested to maintain a medication diary of each dose of medication. The medication diary will be returned to clinic staff at the end of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

FDA approved

0 / 18Eligibility criteria met