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Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Cola

Eligible participants will receive daily dosing of Niraparib.

Anjali Avadhani, MD

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.

Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients With PALB2 Mutations

To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1

To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1

To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

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

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

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

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

To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1

To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1

To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

GlaxoSmithKline

Tempus AI

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors	NCT05169437	Solid Tumor Breast Tumor Colon Tumor, Ma... Lung Tumor Urologic Cancer Pancreatic Canc... Melanoma Metastatic Canc... Locally Advance... Esophageal Canc... Endometrial Can... Head and Neck C...	Niraparib	18 Years -	Tempus AI
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors	NCT05169437	Solid Tumor Breast Tumor Colon Tumor, Ma... Lung Tumor Urologic Cancer Pancreatic Canc... Melanoma Metastatic Canc... Locally Advance... Esophageal Canc... Endometrial Can... Head and Neck C...	Niraparib	18 Years -	Tempus AI

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