Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors (PAVO)

October 15, 2025 updated by: Tempus AI

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Yuma Regional Medical Center
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology
    • California
      • Fountain Valley, California, United States, 92708
        • Memorial Care Medical Center
      • Fullerton, California, United States, 92835
        • St Joseph Heritage Health - Fullerton
      • La Jolla, California, United States, 92093-0698
        • University of California San Diego
      • Long Beach, California, United States, 90806
        • MemorialCare
      • Los Alamitos, California, United States, 90720
        • Cancer and Blood Specialty Clinic
      • Los Alamitos, California, United States, 90720
        • Cancer and Blood Specialty
      • Los Angeles, California, United States, 90404
        • University of California Los Angeles
      • Napa, California, United States, 94558
        • St Joseph Health Medical Group - Napa
      • Oxnard, California, United States, 93030
        • Ventura County Hematology Oncology Specialists
      • San Diego, California, United States, 92123
        • Sharp Healthcare
      • Santa Barbara, California, United States, 93105
        • Ridley-Tree Cancer Center
      • Santa Rosa, California, United States, 95403
        • St Joseph Health Medical Group - Santa Rosa
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Healthcare
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Ocala, Florida, United States, 34474
        • Ocala Community Cancer Center
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Rolling Meadows, Illinois, United States, 60008
        • Northwest Oncology & Hematology
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology
      • Goshen, Indiana, United States, 46526
        • Goshen Health
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network
      • South Bend, Indiana, United States, 46601
        • Beacon Health System
    • Louisiana
      • Hammond, Louisiana, United States, 70403
        • Pontchartrain Cancer Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • The Center for Cancer and Blood Disorders - Maryland
      • Frederick, Maryland, United States, 21702
        • Frederick Health
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology
    • Massachusetts
      • Fairhaven, Massachusetts, United States, 02719
        • Southcoast Health
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Health
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center
      • Saint Joseph, Missouri, United States, 64507
        • Mosaic Life Care
      • Springfield, Missouri, United States, 65807
        • Oncology Hematology Associates
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • New Jersey Cancer Care and Blood Disorders
      • Englewood, New Jersey, United States, 07631
        • Englewood Health
      • Florham Park, New Jersey, United States, 07932
        • Summit Medical Group
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Inc. - Charlotte
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Inc. - Winston-Salem
    • Ohio
      • Canton, Ohio, United States, 44708
        • Aultman Medical Group
      • Cincinnati, Ohio, United States, 45220
        • TriHealth
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Seidman
      • Columbus, Ohio, United States, 43214
        • OhioHealth
      • Toledo, Ohio, United States, 43623
        • The Toledo Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists
    • Oregon
      • Salem, Oregon, United States, 97301
        • Oregon Oncology Specialists
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Gettysburg Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Bon Secours - St. Francis Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford Health
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Cancer Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Oncology - South Austin
      • Austin, Texas, United States, 78705
        • Texas Oncology - Austin Midtown
      • Austin, Texas, United States, 78731
        • Texas Oncology - Austin Central Pharmacy
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Oncology Consultants
      • Longview, Texas, United States, 75601
        • Texas Oncology - Longview Cancer Center
      • Palestine, Texas, United States, 75801
        • Texas Oncology - Palestine Cancer Center
      • Paris, Texas, United States, 75460
        • Texas Oncology - Paris Cancer Center
      • Sugar Land, Texas, United States, 77479
        • LUMI Research
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler Pharmacy
    • Utah
      • Ogden, Utah, United States, 84405
        • Community Cancer Trials of Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Institute
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • Richmond, Virginia, United States, 23229
        • Virginia Cancer Institute
    • Washington
      • Bellingham, Washington, United States, 98225
        • PeaceHealth
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare
      • Madison, Wisconsin, United States, 53717
        • SSM Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
Drug: Niraparib
Eligible participants will receive daily dosing of Niraparib.
Other Names:
  • Zejula

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) - Independent Central Review (ICR)
Time Frame: Up to 4 years
To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1
Up to 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) - Independent Central Review (ICR)
Time Frame: Up to 4 years
To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1
Up to 4 years
Progression-Free Survival (PFS) - Independent Central Review (ICR)
Time Frame: Up to 4 years
To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Up to 4 years
Overall Response Rate (ORR) - Investigator
Time Frame: 2 years 3 months
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).
2 years 3 months
Duration of Response (DOR) - Investigator
Time Frame: 2 years 3 months
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.
2 years 3 months
Progression-Free Survival (PFS) - Investigator
Time Frame: 2 years 3 months
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.
2 years 3 months
Clinical Benefit Rate (CBR) - Investigator and ICR
Time Frame: 2 years 3 months
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).
2 years 3 months
ORR With Untreated Measurable CNS Lesions - Investigator
Time Frame: Up to 4 years
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1
Up to 4 years
ORR With Untreated Measurable CNS Lesions - ICR
Time Frame: Up to 4 years
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1
Up to 4 years
Number of Participants With Treatment-Emergent Adverse Events
Time Frame: 2 years 3 months
To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
2 years 3 months
Overall Survival (OS)
Time Frame: 6 months and 12 months
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.
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tempus AI

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Virginia Rhodes, Tempus AI, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMPS-101
  • IND Number: 159142 (Other Identifier: FDA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings