Niraparib in the Treatment of Patients with Advanced PALB2 Mutated Tumors
- Conditions
- Solid TumorBreast TumorColon Tumor, MalignantUrologic CancerMelanomaMetastatic CancerLung TumorHead and Neck CancerPancreatic CancerEsophageal Cancer
- Interventions
- Registration Number
- NCT05169437
- Lead Sponsor
- Tempus AI
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations Niraparib -
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) - Independent Central Review (ICR) Up to 4 years To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) - Independent Central Review (ICR) 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)
Clinical Benefit Rate (CBR) - Investigator and ICR Up to 4 years To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Up to 4 years 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) Up to 4 years To evaluate overall survival (OS)
Overall Response Rate (ORR) - Investigator Up to 4 years To evaluate ORR as assessed by Investigator using RECIST v1.1
Progression-Free Survival (PFS) - Investigator Up to 4 years To evaluate PFS as assessed by Investigator using RECIST v1.1
ORR with untreated measurable CNS lesions - Investigator Up to 4 years 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 Up to 4 years To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1
Duration of Response (DOR) - Independent Central Review (ICR) Up to 4 years To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1
Duration of Response (DOR) - Investigator Up to 4 years To evaluate DOR as assessed by Investigator using RECIST v1.1
Trial Locations
- Locations (79)
Yuma Regional Medical Center
🇺🇸Yuma, Arizona, United States
Northwest Oncology & Hematology
🇺🇸Rolling Meadows, Illinois, United States
St Joseph Heritage Health - Fullerton
🇺🇸Fullerton, California, United States
Novant Health Inc. - Charlotte
🇺🇸Charlotte, North Carolina, United States
University Cancer & Blood Center
🇺🇸Athens, Georgia, United States
Goshen Health
🇺🇸Goshen, Indiana, United States
Aultman Medical Group
🇺🇸Canton, Ohio, United States
Central Care Cancer Center
🇺🇸Bolivar, Missouri, United States
Frederick Health
🇺🇸Frederick, Maryland, United States
Beacon Health System
🇺🇸South Bend, Indiana, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
Bon Secours - St. Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
MemorialCare
🇺🇸Long Beach, California, United States
Highlands Oncology
🇺🇸Springdale, Arkansas, United States
Community Cancer Trials of Utah
🇺🇸Ogden, Utah, United States
ThedaCare
🇺🇸Appleton, Wisconsin, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
Cancer and Blood Specialty
🇺🇸Los Alamitos, California, United States
Pontchartrain Cancer Center
🇺🇸Hammond, Louisiana, United States
Southcoast Health
🇺🇸Fairhaven, Massachusetts, United States
Lumi Research
🇺🇸Sugar Land, Texas, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Oklahoma Cancer Specialists
🇺🇸Tulsa, Oklahoma, United States
New Jersey Cancer Care and Blood Disorders
🇺🇸Belleville, New Jersey, United States
Sparrow Health
🇺🇸Lansing, Michigan, United States
Oregon Oncology Specialists
🇺🇸Salem, Oregon, United States
Englewood Health
🇺🇸Englewood, New Jersey, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
Sanford Health
🇺🇸Sioux Falls, South Dakota, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
Texas Oncology - Tyler Pharmacy
🇺🇸Tyler, Texas, United States
Southeastern Medical Oncology Center
🇺🇸Goldsboro, North Carolina, United States
The Toledo Clinic
🇺🇸Toledo, Ohio, United States
Texas Oncology - Palestine Cancer Center
🇺🇸Palestine, Texas, United States
Gettysburg Cancer Center
🇺🇸Gettysburg, Pennsylvania, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
PeaceHealth
🇺🇸Bellingham, Washington, United States
Hematology Oncology Associates of Fredericksburg
🇺🇸Fredericksburg, Virginia, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
Inova Schar Institute
🇺🇸Fairfax, Virginia, United States
Cleveland Clinic - Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
University Hospitals Seidman
🇺🇸Cleveland, Ohio, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
OhioHealth
🇺🇸Columbus, Ohio, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
Oncology Consultants
🇺🇸Houston, Texas, United States
OptumCare Cancer Care
🇺🇸Las Vegas, Nevada, United States
TriHealth
🇺🇸Cincinnati, Ohio, United States
Maryland Oncology Hematology
🇺🇸Rockville, Maryland, United States
Holy Cross
🇺🇸Fort Lauderdale, Florida, United States
Ridley-Tree Cancer Center
🇺🇸Santa Barbara, California, United States
Texas Oncology - Longview Cancer Center
🇺🇸Longview, Texas, United States
Memorial Care Medical Center
🇺🇸Fountain Valley, California, United States
Ventura County Hematology Oncology Specialists
🇺🇸Oxnard, California, United States
Texas Oncology - Austin Midtown
🇺🇸Austin, Texas, United States
Texas Oncology - Austin Central Pharmacy
🇺🇸Austin, Texas, United States
Texas Oncology - South Austin
🇺🇸Austin, Texas, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
St Joseph Health Medical Group - Napa
🇺🇸Napa, California, United States
St Joseph Health Medical Group - Santa Rosa
🇺🇸Santa Rosa, California, United States
Eastern Connecticut Hematology and Oncology
🇺🇸Norwich, Connecticut, United States
Hartford Healthcare
🇺🇸Hartford, Connecticut, United States
Ocala Community Cancer Center
🇺🇸Ocala, Florida, United States
Mosaic Life Care
🇺🇸Saint Joseph, Missouri, United States
Texas Oncology - Paris Cancer Center
🇺🇸Paris, Texas, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
The Center for Cancer and Blood Disorders - Maryland
🇺🇸Bethesda, Maryland, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Novant Health Inc. - Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Hawaii Cancer Care
🇺🇸Honolulu, Hawaii, United States
SSM Health
🇺🇸Madison, Wisconsin, United States
Sharp Healthcare
🇺🇸San Diego, California, United States