Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Sponsor
Tempus Labs (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05169437
Collaborator
GlaxoSmithKline (Industry)
110
68
1
39.6
1.6
0

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients With PALB2 Mutations
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    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

    2. 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)

    3. Overall Response Rate (ORR) - Investigator [Up to 4 years]

      To evaluate ORR as assessed by Investigator using RECIST v1.1

    4. Duration of Response (DOR) - Investigator [Up to 4 years]

      To evaluate DOR as assessed by Investigator using RECIST v1.1

    5. Progression-Free Survival (PFS) - Investigator [Up to 4 years]

      To evaluate PFS as assessed by Investigator using RECIST v1.1

    6. Clinical Benefit Rate (CBR) - Investigator and ICR [Up to 4 years]

      To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator

    7. 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

    8. 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

    9. 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)

    10. Overall Survival (OS) [Up to 4 years]

      To evaluate overall survival (OS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yuma Regional Medical Center Yuma Arizona United States 85364
    2 Highlands Oncology Springdale Arkansas United States 72762
    3 St Joseph Heritage Health - Fullerton Fullerton California United States 92835
    4 MemorialCare Long Beach California United States 90806
    5 Cancer and Blood Specialty Los Alamitos California United States 90720
    6 St Joseph Health Medical Group - Napa Napa California United States 94558
    7 Ventura County Hematology Oncology Specialists Oxnard California United States 93030
    8 Sharp Healthcare San Diego California United States 92123
    9 Ridley-Tree Cancer Center Santa Barbara California United States 93105
    10 St Joseph Health Medical Group - Santa Rosa Santa Rosa California United States 95403
    11 Hartford Healthcare Hartford Connecticut United States 06102
    12 Eastern Connecticut Hematology and Oncology Norwich Connecticut United States 06360
    13 Holy Cross Fort Lauderdale Florida United States 33308
    14 Cancer Specialists of North Florida Jacksonville Florida United States 32256
    15 Ocala Community Cancer Center Ocala Florida United States 34474
    16 University Cancer & Blood Center Athens Georgia United States 30607
    17 Hawaii Cancer Care Honolulu Hawaii United States 96813
    18 Northwest Oncology & Hematology Rolling Meadows Illinois United States 60008
    19 Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana United States 46845
    20 Goshen Health Goshen Indiana United States 46526
    21 Community Health Network Indianapolis Indiana United States 46250
    22 Beacon Health System South Bend Indiana United States 46601
    23 Pontchartrain Cancer Center Hammond Louisiana United States 70403
    24 The Center for Cancer and Blood Disorders - Maryland Bethesda Maryland United States 20817
    25 Frederick Health Frederick Maryland United States 21702
    26 Maryland Oncology Hematology Rockville Maryland United States 20850
    27 Southcoast Health Fairhaven Massachusetts United States 02719
    28 Sparrow Health Lansing Michigan United States 48912
    29 Central Care Cancer Center Bolivar Missouri United States 65613
    30 Mosaic Life Care Saint Joseph Missouri United States 64507
    31 Oncology Hematology Associates Springfield Missouri United States 65807
    32 Nebraska Cancer Specialists Omaha Nebraska United States 68130
    33 OptumCare Cancer Care Las Vegas Nevada United States 89102
    34 New Jersey Cancer Care and Blood Disorders Belleville New Jersey United States 07109
    35 Englewood Health Englewood New Jersey United States 07631
    36 Summit Medical Group Florham Park New Jersey United States 07932
    37 Southeastern Medical Oncology Center Goldsboro North Carolina United States 27534
    38 Aultman Medical Group Canton Ohio United States 44708
    39 TriHealth Cincinnati Ohio United States 45220
    40 University Hospitals Seidman Cleveland Ohio United States 44106
    41 OhioHealth Columbus Ohio United States 43214
    42 The Toledo Clinic Toledo Ohio United States 43623
    43 Oklahoma Cancer Specialists Tulsa Oklahoma United States 74146
    44 Oregon Oncology Specialists Salem Oregon United States 97301
    45 Gettysburg Cancer Center Gettysburg Pennsylvania United States 17325
    46 Bon Secours - St. Francis Cancer Center Greenville South Carolina United States 29607
    47 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    48 Sanford Health Sioux Falls South Dakota United States 57117
    49 Baptist Cancer Center Memphis Tennessee United States 38120
    50 Texas Oncology - Austin Midtown Austin Texas United States 78705
    51 Texas Oncology - Austin Central Pharmacy Austin Texas United States 78731
    52 Texas Oncology - South Austin Austin Texas United States 78745
    53 Mary Crowley Cancer Research Dallas Texas United States 75230
    54 Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    55 Oncology Consultants Houston Texas United States 77030
    56 Texas Oncology - Longview Cancer Center Longview Texas United States 75601
    57 Texas Oncology - Palestine Cancer Center Palestine Texas United States 75801
    58 Texas Oncology - Paris Cancer Center Paris Texas United States 75460
    59 Lumi Research Sugar Land Texas United States 77479
    60 Texas Oncology - Tyler Pharmacy Tyler Texas United States 75702
    61 Community Cancer Trials of Utah Ogden Utah United States 84405
    62 Utah Cancer Specialists Salt Lake City Utah United States 84106
    63 Hematology Oncology Associates of Fredericksburg Fredericksburg Virginia United States 22408
    64 Virginia Cancer Institute Richmond Virginia United States 23230
    65 PeaceHealth Bellingham Washington United States 98225
    66 Northwest Medical Specialties Tacoma Washington United States 98405
    67 ThedaCare Appleton Wisconsin United States 54911
    68 SSM Health Madison Wisconsin United States 53717

    Sponsors and Collaborators

    • Tempus Labs
    • GlaxoSmithKline

    Investigators

    • Study Director: Anjali Avadhani, MD, Tempus Labs, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tempus Labs
    ClinicalTrials.gov Identifier:
    NCT05169437
    Other Study ID Numbers:
    • TMPS-101
    • IND Number: 159142
    First Posted:
    Dec 27, 2021
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022

    Study Results

    No Results Posted as of Aug 1, 2022