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Targeted drug shows promise for rare ROS1 cancers

NCT ID NCT04439253

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called crizotinib in people whose cancer has a specific genetic change called ROS1 translocation. The drug blocks a protein that may help cancer grow. Researchers want to see if it can shrink tumors or stop them from getting worse. Only 4 people took part, all with advanced or hard-to-treat cancers other than lung cancer.

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

4 people

The number who actually took part.

Started

Aug 2015

Expected to finish

Mar 2027

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 be positive for translocation or inversion events involving the ROS1 gene 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 NSCLC with ROS1 rearrangements * Patients with a history of interstitial lung disease or pneumonitis are excluded * Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition * Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will be excluded * Patients must not have had prior therapy with any ROS1 inhibitor including crizotinib, ceritinib, foretinib, cabozantinib, AP26113, ASP3026, WZ-5-126, TAE684, KIST301072, KIST301080, AZD1480, PF-06463922, RXDX-101 and PF-3922

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Conditions

The condition(s) this trial relates to.

cancer hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm lymphoma plasma cell myeloma refractory hematologic cancer refractory malignant neoplasm refractory plasma cell 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 Refractory multiple myeloma

Contacts and locations

Locations

  • ECOG-ACRIN Cancer Research Group

    Philadelphia, Pennsylvania, 19103, United States

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