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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 time from registration to the earlier of progression or death due to any cause, for up to 2 years post eot 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 ~ time from registration to the earlier of progression or death due to any cause, for up to 2 years post eot visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from registration to the earlier of progression or death due to any cause, for up to 2 years post eot visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from registration to the earlier of progression or death due to any cause, for up to 2 years post eot 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

Intracranial Clinical Benefit Rate (Cohort 1)

Intracranial Clinical Benefit Rate (Cohort 2)

Secondary study objectives

Extracranial Overall Response Rate

Extracranial disease progression rate of Cohort 1

Incidence of Drug Related Toxicities

+2 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

73%

Palmar-plantar erythrodysesthesia syndrome

58%

Fatigue

56%

Diarrhea

38%

Hypertension

38%

Nausea

30%

Mucositis

29%

Vomiting

26%

Weight loss

26%

Weight gain

24%

Anorexia

20%

Nail disorder

17%

Back pain

16%

Hypothermia

15%

Constipation

15%

Abdominal pain

14%

Neutrophil count decreased

13%

Dizziness

13%

Upper respiratory infection

13%

Headache

11%

Dyspepsia

10%

Pain in extremity

10%

Fever

10%

Obesity

10%

Dysgeusia

Bone pain

Anemia

Arthralgia

Cough

Pruritus

Flu like symptoms

Pain

Alopecia

Thromboembolic event

Bone fracture

Gastrointestinal infection

Spinal cord compression

Febrile neutropenia

Respiratory infection

Hot flashes

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Cohort 2: Palbociclib Plus Fulvestrant

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

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (Palbociclib in Combination with Pembrolizumab)Experimental Treatment2 Interventions

Cohort 2 involves screening for eligibility, study treatment and study visits, and follow up. Participants in Cohort 2 will receive study drugs palbociclib and pembrolizumab. Palbociclib is taken orally once per day for 21 days (Day 1-21) of each 28-day cycle. Pembrolizumab will be administered as an intravenous (IV) infusion once every 21 days. Participants may receive study drugs as long as they do not meet the criteria for ending treatment (no intolerable side effects and disease is not progressing), and will be followed for up to 2 years after they stop study treatment. Up to 15 participants will be enrolled in Cohort 2.

Group II: Cohort 1 (Palbociclib)Experimental Treatment1 Intervention

This arm involves screening for eligibility, study treatment and study visits, and follow up. Cohort 1 participants will receive palbociclib daily at a pre-determined dose for 21 days (Day 1-21) per 28-day cycle. Palbociclib is taken orally. Participants may receive study drug as long as they do not meet the criteria for ending treatment (no intolerable side effects and disease is not progressing). Participants will be followed for up to 2 years after their treatment with the study drug ends. Up to 30 participants will be enrolled in Cohort 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Palbociclib

FDA approved

0 / 18Eligibility criteria met