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Targeted drug palbociclib tested against cancers with specific genetic flaw

NCT ID NCT04439201

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This phase II trial is testing the drug palbociclib in 40 patients whose advanced cancers have extra copies of the CCND1, 2, or 3 genes. Palbociclib blocks proteins that help cancer cells grow. The goal is to see if the drug can shrink tumors or stop them from growing. The study is for patients with solid tumors or lymphomas that have not responded to other treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Palbociclib (a targeted cancer drug that blocks CDK4 and CDK6 proteins)
What this could lead to
If successful, this could provide a new treatment option for patients with certain genetic changes in their tumors, potentially shrinking or slowing cancer growth.
What could go wrong
This is a small, early-phase trial (40 patients) with no control group, so results may not apply broadly. The drug may not work for all tumor types, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

May 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol * Patients must have amplification of CCND1, 2, or 3, or another aberration, as determined via the MATCH Master Protocol * 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) Exclusion Criteria: * Patients must not have known hypersensitivity to palbociclib or compounds of similar chemical or biologic composition * Patients must not have breast cancer, mantle cell lymphoma or myeloma * Patients with known or symptoms of left ventricular dysfunction will be excluded * Patients must not have had prior treatment with palbociclib, ribociclib, abemaciclib or any other CDK4/6 inhibitors * Patients must not be using drugs or foods that are known potent CYP3A4 inhibitors or inducers, or are CYP3A4 substrates with narrow therapeutic indices

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Conditions

The condition(s) this trial relates to.

cancer hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm lymphoma refractory hematologic cancer refractory malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced lymphoma Advanced malignant solid neoplasm Hematopoietic and lymphoid cell neoplasm Refractory lymphoma Refractory malignant solid neoplasm

Contacts and locations

Locations

  • ECOG-ACRIN Cancer Research Group

    Philadelphia, Pennsylvania, 19103, United States

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