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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05169437
Other study ID # TMPS-101
Secondary ID IND Number: 1591
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 15, 2022
Est. completion date January 1, 2025

Study information

Verified date January 2024
Source Tempus AI
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 22
Est. completion date January 1, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Breast Neoplasms
  • Breast Tumor
  • Colonic Neoplasms
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Esophageal Cancer
  • Esophageal Neoplasms
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Locally Advanced Solid Tumor
  • Lung Neoplasms
  • Lung Tumor
  • Melanoma
  • Metastatic Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Solid Tumor
  • Urologic Cancer
  • Urologic Neoplasms

Intervention

Drug:
Niraparib
Eligible participants will receive daily dosing of Niraparib.

Locations

Country Name City State
United States ThedaCare Appleton Wisconsin
United States University Cancer & Blood Center Athens Georgia
United States Texas Oncology - Austin Central Pharmacy Austin Texas
United States Texas Oncology - Austin Midtown Austin Texas
United States Texas Oncology - South Austin Austin Texas
United States New Jersey Cancer Care and Blood Disorders Belleville New Jersey
United States PeaceHealth Bellingham Washington
United States The Center for Cancer and Blood Disorders - Maryland Bethesda Maryland
United States Central Care Cancer Center Bolivar Missouri
United States Aultman Medical Group Canton Ohio
United States Novant Health Inc. - Charlotte Charlotte North Carolina
United States Rush University Medical Center Chicago Illinois
United States TriHealth Cincinnati Ohio
United States Cleveland Clinic - Taussig Cancer Center Cleveland Ohio
United States University Hospitals Seidman Cleveland Ohio
United States OhioHealth Columbus Ohio
United States Mary Crowley Cancer Research Dallas Texas
United States Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas
United States The University of Texas Southwestern Medical Center Dallas Texas
United States Englewood Health Englewood New Jersey
United States Inova Schar Institute Fairfax Virginia
United States Southcoast Health Fairhaven Massachusetts
United States Summit Medical Group Florham Park New Jersey
United States Holy Cross Fort Lauderdale Florida
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Memorial Care Medical Center Fountain Valley California
United States Frederick Health Frederick Maryland
United States Hematology Oncology Associates of Fredericksburg Fredericksburg Virginia
United States St Joseph Heritage Health - Fullerton Fullerton California
United States Gettysburg Cancer Center Gettysburg Pennsylvania
United States Southeastern Medical Oncology Center Goldsboro North Carolina
United States Goshen Health Goshen Indiana
United States Bon Secours - St. Francis Cancer Center Greenville South Carolina
United States Pontchartrain Cancer Center Hammond Louisiana
United States Hartford Healthcare Hartford Connecticut
United States Hawaii Cancer Care Honolulu Hawaii
United States Oncology Consultants Houston Texas
United States Community Health Network Indianapolis Indiana
United States Cancer Specialists of North Florida Jacksonville Florida
United States University of California San Diego La Jolla California
United States Sparrow Health Lansing Michigan
United States OptumCare Cancer Care Las Vegas Nevada
United States MemorialCare Long Beach California
United States Texas Oncology - Longview Cancer Center Longview Texas
United States Cancer and Blood Specialty Los Alamitos California
United States Cancer and Blood Specialty Clinic Los Alamitos California
United States University of California Los Angeles Los Angeles California
United States SSM Health Madison Wisconsin
United States Baptist Cancer Center Memphis Tennessee
United States St Joseph Health Medical Group - Napa Napa California
United States Vanderbilt University Nashville Tennessee
United States Eastern Connecticut Hematology and Oncology Norwich Connecticut
United States Ocala Community Cancer Center Ocala Florida
United States Community Cancer Trials of Utah Ogden Utah
United States Nebraska Cancer Specialists Omaha Nebraska
United States Ventura County Hematology Oncology Specialists Oxnard California
United States Texas Oncology - Palestine Cancer Center Palestine Texas
United States Texas Oncology - Paris Cancer Center Paris Texas
United States Virginia Cancer Institute Richmond Virginia
United States Virginia Cancer Institute Richmond Virginia
United States Maryland Oncology Hematology Rockville Maryland
United States Northwest Oncology & Hematology Rolling Meadows Illinois
United States Mosaic Life Care Saint Joseph Missouri
United States Oregon Oncology Specialists Salem Oregon
United States Utah Cancer Specialists Salt Lake City Utah
United States Sharp Healthcare San Diego California
United States Ridley-Tree Cancer Center Santa Barbara California
United States St Joseph Health Medical Group - Santa Rosa Santa Rosa California
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Health Sioux Falls South Dakota
United States Beacon Health System South Bend Indiana
United States Highlands Oncology Springdale Arkansas
United States Oncology Hematology Associates Springfield Missouri
United States Lumi Research Sugar Land Texas
United States Northwest Medical Specialties Tacoma Washington
United States The Toledo Clinic Toledo Ohio
United States Oklahoma Cancer Specialists Tulsa Oklahoma
United States Texas Oncology - Tyler Pharmacy Tyler Texas
United States Novant Health Inc. - Winston-Salem Winston-Salem North Carolina
United States Yuma Regional Medical Center Yuma Arizona

Sponsors (2)

Lead Sponsor Collaborator
Tempus AI GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 4 years
Secondary Duration of Response (DOR) - Independent Central Review (ICR) To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1 Up to 4 years
Secondary 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) Up to 4 years
Secondary Overall Response Rate (ORR) - Investigator To evaluate ORR as assessed by Investigator using RECIST v1.1 Up to 4 years
Secondary Duration of Response (DOR) - Investigator To evaluate DOR as assessed by Investigator using RECIST v1.1 Up to 4 years
Secondary Progression-Free Survival (PFS) - Investigator To evaluate PFS as assessed by Investigator using RECIST v1.1 Up to 4 years
Secondary Clinical Benefit Rate (CBR) - Investigator and ICR To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator Up to 4 years
Secondary 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 Up to 4 years
Secondary 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 Up to 4 years
Secondary 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) Up to 4 years
Secondary Overall Survival (OS) To evaluate overall survival (OS) Up to 4 years
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