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CDK4/6 Inhibitor

Palbociclib for Advanced Solid Cancers and Non-Hodgkin Lymphoma

Phase 2

Waitlist Available

Led By Rajen Mody

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

For patients with solid tumors without known bone marrow involvement

In addition to the actionable mutations, positive Rb expression by immunohistochemistry is required for study enrollment

Must not have

Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial

Patients who have an uncontrolled infection are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well palbociclib works in treating pediatric patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders.

Who is the study for?

This trial is for children and young adults aged up to 21 with Rb positive advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have returned or are treatment-resistant. Participants must have measurable disease, adequate organ function, no prior CDK4/6 inhibitors like palbociclib use, and be able to swallow capsules. Pregnant individuals or those on certain medications are excluded.

What is being tested?

The study tests the effectiveness of palbociclib in treating patients with specific cancer types that have genetic alterations affecting cell growth. It aims to see if this drug can stop cancer cells by inhibiting proteins necessary for their proliferation.

What are the potential side effects?

Palbociclib may cause low blood cell counts leading to increased infection risk, bleeding issues, fatigue; nausea; hair thinning; rash; diarrhea; mouth sores; loss of appetite and potential liver problems as indicated by changes in blood tests.

Eligibility Criteria

Inclusion Criteria

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

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My solid tumor cancer has not spread to my bone marrow.

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My cancer cells show positive Rb expression.

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I am enrolled in APEC1621SC and assigned to APEC1621I due to a specific mutation.

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I can swallow pills without any issues.

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I have received a stem cell infusion, with or without full-body radiation.

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I have never taken drugs like palbociclib or any CDK4/6 inhibitors.

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My kidney function is within the normal range for my age and gender.

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My bilirubin levels are within the normal range for my age.

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My body surface area is at least 0.87 square meters.

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I have received radiation therapy.

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I am between 12 and 21 years old.

Exclusion Criteria

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

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I am not taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I do not have any infections that are not under control.

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I am not currently taking any cancer treatment drugs.

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I have been on a stable or decreasing dose of corticosteroids for at least 7 days.

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I am not currently taking any experimental drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 years 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

Secondary study objectives

Percentage of Patients Experiencing Grade 3 or Higher Adverse Events

Progression Free Survival (PFS)

Other study objectives

Changes in Tumor Genomics Over Time Through Evaluation of Circulating Tumor Deoxyribonucleic Acid

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 Treatment3 Interventions

Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years 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

~3880

0 / 16Eligibility criteria met