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Solid TumorPhase 2PAVONCT05169437

Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

A Phase 2 study testing Niraparib in people with Solid Tumor and Breast Tumor, run by Tempus AI at 80 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Breast Tumor, Colon Tumor, Malignant
What is being tested?
Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
80 sitesUnited States
Study dates
15 Mar 2022to 27 Aug 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

80 sites in 1 country.

80 sites in 1 country

United States80 sites

  • ThedaCare

    Appleton, Wisconsin, 54911

  • University Cancer & Blood Center

    Athens, Georgia, 30607

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology - Austin Central Pharmacy

    Austin, Texas, 78731

  • Texas Oncology - South Austin

    Austin, Texas, 78745

  • New Jersey Cancer Care and Blood Disorders

    Belleville, New Jersey, 07109

  • PeaceHealth

    Bellingham, Washington, 98225

  • The Center for Cancer and Blood Disorders - Maryland

    Bethesda, Maryland, 20817

  • Central Care Cancer Center

    Bolivar, Missouri, 65613

  • Aultman Medical Group

    Canton, Ohio, 44708

  • Novant Health Inc. - Charlotte

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • TriHealth

    Cincinnati, Ohio, 45220

  • University Hospitals Seidman

    Cleveland, Ohio, 44106

  • Cleveland Clinic - Taussig Cancer Center

    Cleveland, Ohio, 44195

  • OhioHealth

    Columbus, Ohio, 43214

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Englewood Health

    Englewood, New Jersey, 07631

  • Inova Schar Institute

    Fairfax, Virginia, 22031

  • Southcoast Health

    Fairhaven, Massachusetts, 02719

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • Holy Cross

    Fort Lauderdale, Florida, 33308

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Memorial Care Medical Center

    Fountain Valley, California, 92708

  • Frederick Health

    Frederick, Maryland, 21702

  • Hematology Oncology Associates of Fredericksburg

    Fredericksburg, Virginia, 22408

  • St Joseph Heritage Health - Fullerton

    Fullerton, California, 92835

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Goshen Health

    Goshen, Indiana, 46526

  • Bon Secours - St. Francis Cancer Center

    Greenville, South Carolina, 29607

  • Pontchartrain Cancer Center

    Hammond, Louisiana, 70403

  • Hartford Healthcare

    Hartford, Connecticut, 06102

  • Hawaii Cancer Care

    Honolulu, Hawaii, 96813

  • Oncology Consultants

    Houston, Texas, 77030

  • Community Health Network

    Indianapolis, Indiana, 46250

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • University of California San Diego

    La Jolla, California, 92093-0698

  • Sparrow Health

    Lansing, Michigan, 48912

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89102

  • MemorialCare

    Long Beach, California, 90806

  • Texas Oncology - Longview Cancer Center

    Longview, Texas, 75601

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • Cancer and Blood Specialty

    Los Alamitos, California, 90720

  • University of California Los Angeles

    Los Angeles, California, 90404

  • SSM Health

    Madison, Wisconsin, 53717

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • St Joseph Health Medical Group - Napa

    Napa, California, 94558

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Eastern Connecticut Hematology and Oncology

    Norwich, Connecticut, 06360

  • Ocala Community Cancer Center

    Ocala, Florida, 34474

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Texas Oncology - Palestine Cancer Center

    Palestine, Texas, 75801

  • Texas Oncology - Paris Cancer Center

    Paris, Texas, 75460

  • Virginia Cancer Institute

    Richmond, Virginia, 23229

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Maryland Oncology Hematology

    Rockville, Maryland, 20850

  • Northwest Oncology & Hematology

    Rolling Meadows, Illinois, 60008

  • Mosaic Life Care

    Saint Joseph, Missouri, 64507

  • Oregon Oncology Specialists

    Salem, Oregon, 97301

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Sharp Healthcare

    San Diego, California, 92123

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 93105

  • St Joseph Health Medical Group - Santa Rosa

    Santa Rosa, California, 95403

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford Health

    Sioux Falls, South Dakota, 57117

  • Beacon Health System

    South Bend, Indiana, 46601

  • Highlands Oncology

    Springdale, Arkansas, 72762

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

  • Lumi Research

    Sugar Land, Texas, 77479

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • The Toledo Clinic

    Toledo, Ohio, 43623

  • Oklahoma Cancer Specialists

    Tulsa, Oklahoma, 74146

  • Texas Oncology - Tyler Pharmacy

    Tyler, Texas, 75702

  • Novant Health Inc. - Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

About this study

Official title: A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients With PALB2 Mutations

The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation.

Being tested
Niraparib
Keywords
PALB2, Solid Tumor, Metastatic Solid Tumor, Locally Advanced Solid Tumor, Advanced Solid Tumor, Local Solid Tumor, PALB2 Mutation, Niraparib, tPALB2, tPALB2 Mutation, Pathogenic tumor, Lung Tumor, Breast Tumor, Colon Tumor, Zejula, Pancreatic Cancer, Urologic Cancer, Melanoma, Metastatic Cancer, Head and Neck Cancer
Medical subject headings
Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Urologic Neoplasms, Pancreatic Neoplasms, Melanoma, Neoplasm Metastasis, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Also called Zejula

    Eligible participants will receive daily dosing of Niraparib.

Study groups in NCT05169437
Study groupRoleWhat they receive
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 MutationsExperimentalNot described
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR) - Independent Central Review (ICR)

    To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1

    Measured: Up to 4 years

Secondary outcomes (10)

  1. Duration of Response (DOR) - Independent Central Review (ICR)

    To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1

    Measured: Up to 4 years

  2. Progression-Free Survival (PFS) - Independent Central Review (ICR)

    To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Measured: Up to 4 years

  3. Overall Response Rate (ORR) - Investigator

    To evaluate ORR as defined as the proportion of patients who had a partial or complete response (PR or CR) to therapy, as assessed by Investigator using RECIST v1.1 and assessed periodically throughout the treatment period based on imaging every 8 weeks (56 ± 7 days).

    Measured: 2 years 3 months

  4. Duration of Response (DOR) - Investigator

    To evaluate DOR as assessed by Investigator using RECIST v1.1 defined as from first documentation of objective tumor response (CR or PR) to first documentation of objective tumor progression or death due to any cause.

    Measured: 2 years 3 months

  5. Progression-Free Survival (PFS) - Investigator

    To evaluate PFS as assessed by Investigator using RECIST v1.1 determined from the first dose to the date of first radiographic progression or death from any cause in the absence of progression, whichever occurred first, or were censored.

    Measured: 2 years 3 months

  6. Clinical Benefit Rate (CBR) - Investigator and ICR

    To evaluate Clinical Benefit Rate (CBR), defined as the percentage of patients who had achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for 8 weeks or more, as assessed by Investigator only (ICR not performed due to early study termination).

    Measured: 2 years 3 months

  7. ORR With Untreated Measurable CNS Lesions - Investigator

    To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1

    Measured: Up to 4 years

  8. ORR With Untreated Measurable CNS Lesions - ICR

    To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1

    Measured: Up to 4 years

  9. Number of Participants With Treatment-Emergent Adverse Events

    To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

    Measured: 2 years 3 months

  10. Overall Survival (OS)

    To evaluate overall survival (OS) defined as the time from the date of first dose of study drug to the date of death by any cause. Patients who were alive were censored at the date of last contact.

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2021
  2. Study start15 Mar 2022
  3. Primary completion6 Aug 2024
  4. Study completion27 Aug 2024

Why it stopped: Recruitment challenges

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169437
Sponsor's protocol ID
TMPS-101
Other IDs
IND Number: 159142
Acronym
PAVO
Status last verified
Oct 2025
First submitted
13 Dec 2021
Last updated
29 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Solid Tumor and Breast Tumor, run by Tempus AI at 80 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) - Independent Central Review (ICR) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05169437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.

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