Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
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Drug: Niraparib
Eligible participants will receive daily dosing of Niraparib.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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)
- Overall Response Rate (ORR) - Investigator [Up to 4 years]
To evaluate ORR as assessed by Investigator using RECIST v1.1
- Duration of Response (DOR) - Investigator [Up to 4 years]
To evaluate DOR 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
- Clinical Benefit Rate (CBR) - Investigator and ICR [Up to 4 years]
To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants must be at least 18 years of age or older.
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Participants must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor(s).
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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.
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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.
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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.
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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:
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Participants have other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.
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Participants who have ovarian or prostate cancer.
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Participants who have variants of undetermined significance (VUS), but not pathogenic variants of PALB2, at the time of screening.
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Participants who relapsed while receiving platinum based therapy in the adjuvant/curative setting.
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Participants progressing within 14-18 weeks while receiving platinum based therapy in the metastatic setting.
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Participants who have received Poly (ADP-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.
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Participants with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage.
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Participants with germline or somatic BRCA1 or BRCA2 mutations.
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Participant has systolic blood pressure (BP) over 140 mmHg or diastolic BP over 90 mmHg, despite optimal medical therapy.
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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.
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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 | |
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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.- TMPS-101
- IND Number: 159142