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

Primary Purpose

Solid Tumor, Breast Tumor, Colon Tumor, Malignant

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Niraparib
Sponsored by
Tempus Labs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring 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, Endometrial Cancer, Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yuma Regional Medical CenterRecruiting
  • Highlands OncologyRecruiting
  • Memorial Care Medical CenterRecruiting
  • St Joseph Heritage Health - FullertonRecruiting
  • University of California San DiegoRecruiting
  • MemorialCareRecruiting
  • Cancer and Blood Specialty ClinicRecruiting
  • Cancer and Blood SpecialtyRecruiting
  • University of California Los AngelesRecruiting
  • St Joseph Health Medical Group - NapaRecruiting
  • Ventura County Hematology Oncology SpecialistsRecruiting
  • Sharp HealthcareRecruiting
  • Ridley-Tree Cancer CenterRecruiting
  • St Joseph Health Medical Group - Santa RosaRecruiting
  • Hartford HealthcareRecruiting
  • Eastern Connecticut Hematology and OncologyRecruiting
  • Holy CrossRecruiting
  • Cancer Specialists of North FloridaRecruiting
  • Ocala Community Cancer CenterRecruiting
  • University Cancer & Blood CenterRecruiting
  • Hawaii Cancer CareRecruiting
  • Rush University Medical CenterRecruiting
  • Northwest Oncology & HematologyRecruiting
  • Fort Wayne Medical Oncology and HematologyRecruiting
  • Goshen HealthRecruiting
  • Community Health NetworkRecruiting
  • Beacon Health SystemRecruiting
  • Pontchartrain Cancer CenterRecruiting
  • The Center for Cancer and Blood Disorders - MarylandRecruiting
  • Frederick HealthRecruiting
  • Maryland Oncology HematologyRecruiting
  • Southcoast HealthRecruiting
  • Sparrow HealthRecruiting
  • Central Care Cancer CenterRecruiting
  • Mosaic Life CareRecruiting
  • Oncology Hematology AssociatesRecruiting
  • Nebraska Cancer SpecialistsRecruiting
  • OptumCare Cancer CareRecruiting
  • New Jersey Cancer Care and Blood DisordersRecruiting
  • Englewood HealthRecruiting
  • Summit Medical GroupRecruiting
  • Novant Health Inc. - CharlotteRecruiting
  • Southeastern Medical Oncology CenterRecruiting
  • Novant Health Inc. - Winston-SalemRecruiting
  • Aultman Medical GroupRecruiting
  • TriHealthRecruiting
  • University Hospitals SeidmanRecruiting
  • Cleveland Clinic - Taussig Cancer CenterRecruiting
  • OhioHealthRecruiting
  • The Toledo ClinicRecruiting
  • Oklahoma Cancer SpecialistsRecruiting
  • Oregon Oncology SpecialistsRecruiting
  • Gettysburg Cancer CenterRecruiting
  • Bon Secours - St. Francis Cancer CenterRecruiting
  • Avera Cancer InstituteRecruiting
  • Sanford HealthRecruiting
  • Baptist Cancer CenterRecruiting
  • Vanderbilt UniversityRecruiting
  • Texas Oncology - Austin MidtownRecruiting
  • Texas Oncology - Austin Central PharmacyRecruiting
  • Texas Oncology - South AustinRecruiting
  • Mary Crowley Cancer ResearchRecruiting
  • Texas Oncology - Baylor Charles A. Sammons Cancer CenterRecruiting
  • The University of Texas Southwestern Medical CenterRecruiting
  • Oncology ConsultantsRecruiting
  • Texas Oncology - Longview Cancer CenterRecruiting
  • Texas Oncology - Palestine Cancer CenterRecruiting
  • Texas Oncology - Paris Cancer CenterRecruiting
  • Lumi ResearchRecruiting
  • Texas Oncology - Tyler PharmacyRecruiting
  • Community Cancer Trials of UtahRecruiting
  • Utah Cancer SpecialistsRecruiting
  • Inova Schar InstituteRecruiting
  • Hematology Oncology Associates of FredericksburgRecruiting
  • Virginia Cancer InstituteRecruiting
  • Virginia Cancer InstituteRecruiting
  • PeaceHealthRecruiting
  • Northwest Medical SpecialtiesRecruiting
  • ThedaCareRecruiting
  • SSM HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of Response (DOR) - Independent Central Review (ICR)
To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1
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)
Overall Response Rate (ORR) - Investigator
To evaluate ORR as assessed by Investigator using RECIST v1.1
Duration of Response (DOR) - Investigator
To evaluate DOR as assessed by Investigator using RECIST v1.1
Progression-Free Survival (PFS) - Investigator
To evaluate PFS as assessed by Investigator using RECIST v1.1
Clinical Benefit Rate (CBR) - Investigator and ICR
To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator
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
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
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Overall Survival (OS)
To evaluate overall survival (OS)

Full Information

First Posted
December 13, 2021
Last Updated
September 27, 2023
Sponsor
Tempus Labs
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05169437
Brief Title
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
Acronym
PAVO
Official Title
A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients With PALB2 Mutations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tempus Labs
Collaborators
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Breast Tumor, Colon Tumor, Malignant, Lung Tumor, Urologic Cancer, Pancreatic Cancer, Melanoma, Metastatic Cancer, Locally Advanced Solid Tumor, Esophageal Cancer, Endometrial Cancer, Head and Neck Cancer
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, Endometrial Cancer, Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Niraparib
Other Intervention Name(s)
Zejula
Intervention Description
Eligible participants will receive daily dosing of Niraparib.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) - Independent Central Review (ICR)
Description
To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) - Independent Central Review (ICR)
Description
To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1
Time Frame
Up to 4 years
Title
Progression-Free Survival (PFS) - Independent Central Review (ICR)
Description
To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time Frame
Up to 4 years
Title
Overall Response Rate (ORR) - Investigator
Description
To evaluate ORR as assessed by Investigator using RECIST v1.1
Time Frame
Up to 4 years
Title
Duration of Response (DOR) - Investigator
Description
To evaluate DOR as assessed by Investigator using RECIST v1.1
Time Frame
Up to 4 years
Title
Progression-Free Survival (PFS) - Investigator
Description
To evaluate PFS as assessed by Investigator using RECIST v1.1
Time Frame
Up to 4 years
Title
Clinical Benefit Rate (CBR) - Investigator and ICR
Description
To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator
Time Frame
Up to 4 years
Title
ORR with untreated measurable CNS lesions - Investigator
Description
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1
Time Frame
Up to 4 years
Title
ORR with untreated measurable CNS lesions - ICR
Description
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1
Time Frame
Up to 4 years
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Time Frame
Up to 4 years
Title
Overall Survival (OS)
Description
To evaluate overall survival (OS)
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brad Johnson
Phone
(630)687-5723
Email
pavo@tempus.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anjali Avadhani, MD
Email
pavo@tempus.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjali Avadhani, MD
Organizational Affiliation
Tempus Labs, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Yuma Regional Medical Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Individual Site Status
Recruiting
Facility Name
Highlands Oncology
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Care Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
St Joseph Heritage Health - Fullerton
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Individual Site Status
Recruiting
Facility Name
MemorialCare
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer and Blood Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer and Blood Specialty
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
St Joseph Health Medical Group - Napa
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Individual Site Status
Recruiting
Facility Name
Ventura County Hematology Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Individual Site Status
Recruiting
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Ridley-Tree Cancer Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Name
St Joseph Health Medical Group - Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Name
Hartford Healthcare
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Connecticut Hematology and Oncology
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Recruiting
Facility Name
Holy Cross
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Ocala Community Cancer Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
Facility Name
University Cancer & Blood Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Recruiting
Facility Name
Hawaii Cancer Care
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Oncology & Hematology
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Name
Goshen Health
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Individual Site Status
Recruiting
Facility Name
Community Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
Beacon Health System
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Individual Site Status
Recruiting
Facility Name
Pontchartrain Cancer Center
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Individual Site Status
Recruiting
Facility Name
The Center for Cancer and Blood Disorders - Maryland
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
Frederick Health
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryland Oncology Hematology
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Southcoast Health
City
Fairhaven
State/Province
Massachusetts
ZIP/Postal Code
02719
Country
United States
Individual Site Status
Recruiting
Facility Name
Sparrow Health
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Care Cancer Center
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Individual Site Status
Recruiting
Facility Name
Mosaic Life Care
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology Associates
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Name
OptumCare Cancer Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
New Jersey Cancer Care and Blood Disorders
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109
Country
United States
Individual Site Status
Recruiting
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Inc. - Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Inc. - Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Aultman Medical Group
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Individual Site Status
Recruiting
Facility Name
TriHealth
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Seidman
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic - Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
OhioHealth
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
The Toledo Clinic
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Recruiting
Facility Name
Oklahoma Cancer Specialists
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Oncology Specialists
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Individual Site Status
Recruiting
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Individual Site Status
Recruiting
Facility Name
Bon Secours - St. Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Austin Central Pharmacy
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Palestine Cancer Center
City
Palestine
State/Province
Texas
ZIP/Postal Code
75801
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Paris Cancer Center
City
Paris
State/Province
Texas
ZIP/Postal Code
75460
Country
United States
Individual Site Status
Recruiting
Facility Name
Lumi Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Tyler Pharmacy
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Recruiting
Facility Name
Inova Schar Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Associates of Fredericksburg
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Individual Site Status
Recruiting
Facility Name
PeaceHealth
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
ThedaCare
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States
Individual Site Status
Recruiting
Facility Name
SSM Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

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