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Targeted drug shows promise for rare genetic cancers

NCT ID NCT05169437

Disease control Sponsor: Tempus AI 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a drug called niraparib in 22 adults with advanced solid tumors (like breast, lung, or pancreatic cancer) that have a specific genetic change called a PALB2 mutation. The goal was to see if the drug could shrink tumors or slow cancer growth. The study was stopped early, but results may still help understand how to treat these rare cancers.

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

22 people

The number who actually took part.

Started

Mar 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Participants must be at least 18 years of age or older. * Participants must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor(s). * Participants must have tested positive for a pathogenic or likely pathogenic tPALB2 gene mutation using a CLIA-certified laboratory as described in the Next-Generation Sequencing (NGS) Laboratory Manual. * Participants who have stable and asymptomatic Central Nervous System (CNS) disease must be receiving a stable (for at least 7 days) or decreasing corticosteroid dose at the time of study entry. * Participants must submit fresh or archived (collected within 24 months of enrollment) Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample to the central laboratory for post-enrollment confirmation of tPALB2 status. * Participants must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or the participant has no satisfactory alternative treatments. Exclusion Criteria: * Participants have other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy. * Participants who have ovarian or prostate cancer. * Participants who have variants of undetermined significance (VUS), but not pathogenic variants of PALB2, at the time of screening. * Participants who relapsed while receiving platinum based therapy in the adjuvant/curative setting. * Participants progressing within 14-18 weeks while receiving platinum based therapy in the metastatic setting. * Participants who have received Poly (ADP-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment. * Participants with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. * Participants with germline or somatic BRCA1 or BRCA2 mutations. * Participant has systolic blood pressure (BP) over 140 mmHg or diastolic BP over 90 mmHg, despite optimal medical therapy. * Participants have previously or are currently participating in a treatment study of an investigational agent within 3 weeks of the first dose of therapy preceding the study. * Participants have received prior systemic cytotoxic chemotherapy, biological therapy, or hormonal therapy for cancer, or received radiation therapy within 3 weeks of the first dose therapy preceding the study.

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm breast cancer breast neoplasm colonic neoplasm endometrial cancer endometrium neoplasm esophageal cancer Esophageal Neoplasms head and neck cancer Head and Neck Neoplasms lung neoplasm malignant colon neoplasm malignant pancreatic neoplasm malignant urinary system neoplasm melanoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis pancreatic neoplasm

As listed by the trial registrant

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

Breast tumor Colon tumor, malignant Endometrial cancer Esophageal cancer Head and neck cancer Locally advanced solid tumor Lung tumor Melanoma Metastatic cancer Pancreatic cancer Solid tumor Urologic cancer

Contacts and locations

Locations

  • Aultman Medical Group

    Canton, Ohio, 44708, United States

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Beacon Health System

    South Bend, Indiana, 46601, United States

  • Bon Secours - St. Francis Cancer Center

    Greenville, South Carolina, 29607, United States

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Cancer and Blood Specialty

    Los Alamitos, California, 90720, United States

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720, United States

  • Central Care Cancer Center

    Bolivar, Missouri, 65613, United States

  • Cleveland Clinic - Taussig Cancer Center

    Cleveland, Ohio, 44195, United States

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

  • Community Health Network

    Indianapolis, Indiana, 46250, United States

  • Eastern Connecticut Hematology and Oncology

    Norwich, Connecticut, 06360, United States

  • Englewood Health

    Englewood, New Jersey, 07631, United States

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845, United States

  • Frederick Health

    Frederick, Maryland, 21702, United States

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325, United States

  • Goshen Health

    Goshen, Indiana, 46526, United States

  • Hartford Healthcare

    Hartford, Connecticut, 06102, United States

  • Hawaii Cancer Care

    Honolulu, Hawaii, 96813, United States

  • Hematology Oncology Associates of Fredericksburg

    Fredericksburg, Virginia, 22408, United States

  • Highlands Oncology

    Springdale, Arkansas, 72762, United States

  • Holy Cross

    Fort Lauderdale, Florida, 33308, United States

  • Inova Schar Institute

    Fairfax, Virginia, 22031, United States

  • Lumi Research

    Sugar Land, Texas, 77479, United States

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Maryland Oncology Hematology

    Rockville, Maryland, 20850, United States

  • Memorial Care Medical Center

    Fountain Valley, California, 92708, United States

  • MemorialCare

    Long Beach, California, 90806, United States

  • Mosaic Life Care

    Saint Joseph, Missouri, 64507, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • New Jersey Cancer Care and Blood Disorders

    Belleville, New Jersey, 07109, United States

  • Northwest Medical Specialties

    Tacoma, Washington, 98405, United States

  • Northwest Oncology & Hematology

    Rolling Meadows, Illinois, 60008, United States

  • Novant Health Inc. - Charlotte

    Charlotte, North Carolina, 28204, United States

  • Novant Health Inc. - Winston-Salem

    Winston-Salem, North Carolina, 27103, United States

  • Ocala Community Cancer Center

    Ocala, Florida, 34474, United States

  • OhioHealth

    Columbus, Ohio, 43214, United States

  • Oklahoma Cancer Specialists

    Tulsa, Oklahoma, 74146, United States

  • Oncology Consultants

    Houston, Texas, 77030, United States

  • Oncology Hematology Associates

    Springfield, Missouri, 65807, United States

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89102, United States

  • Oregon Oncology Specialists

    Salem, Oregon, 97301, United States

  • PeaceHealth

    Bellingham, Washington, 98225, United States

  • Pontchartrain Cancer Center

    Hammond, Louisiana, 70403, United States

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 93105, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • SSM Health

    Madison, Wisconsin, 53717, United States

  • Sanford Health

    Sioux Falls, South Dakota, 57117, United States

  • Sharp Healthcare

    San Diego, California, 92123, United States

  • Southcoast Health

    Fairhaven, Massachusetts, 02719, United States

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534, United States

  • Sparrow Health

    Lansing, Michigan, 48912, United States

  • St Joseph Health Medical Group - Napa

    Napa, California, 94558, United States

  • St Joseph Health Medical Group - Santa Rosa

    Santa Rosa, California, 95403, United States

  • St Joseph Heritage Health - Fullerton

    Fullerton, California, 92835, United States

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • Texas Oncology - Austin Central Pharmacy

    Austin, Texas, 78731, United States

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705, United States

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology - Longview Cancer Center

    Longview, Texas, 75601, United States

  • Texas Oncology - Palestine Cancer Center

    Palestine, Texas, 75801, United States

  • Texas Oncology - Paris Cancer Center

    Paris, Texas, 75460, United States

  • Texas Oncology - South Austin

    Austin, Texas, 78745, United States

  • Texas Oncology - Tyler Pharmacy

    Tyler, Texas, 75702, United States

  • The Center for Cancer and Blood Disorders - Maryland

    Bethesda, Maryland, 20817, United States

  • The Toledo Clinic

    Toledo, Ohio, 43623, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • ThedaCare

    Appleton, Wisconsin, 54911, United States

  • TriHealth

    Cincinnati, Ohio, 45220, United States

  • University Cancer & Blood Center

    Athens, Georgia, 30607, United States

  • University Hospitals Seidman

    Cleveland, Ohio, 44106, United States

  • University of California Los Angeles

    Los Angeles, California, 90404, United States

  • University of California San Diego

    La Jolla, California, 92093-0698, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030, United States

  • Virginia Cancer Institute

    Richmond, Virginia, 23229, United States

  • Virginia Cancer Institute

    Richmond, Virginia, 23230, United States

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.