Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Conditions

• Breast Tumor
• Colon Tumor, Malignant
• Endometrial Cancer
• Esophageal Cancer
• Head and Neck Cancer
• Locally Advanced Solid Tumor
• Lung Tumor
• Melanoma
• Metastatic Cancer
• Pancreatic Cancer
• Solid Tumor
• Urologic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Niraparib — DRUG
  Eligible participants will receive daily dosing of Niraparib.

Study Details

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.

Key Dates

Start date

Mar 15, 2022

Status verified

Oct 2025

Primary completion

Aug 6, 2024

Completion

Aug 27, 2024

Study Design

Enrollment

22 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations

Primary Outcome Measure

Overall Response Rate (ORR) - Independent Central Review (ICR) [ Time Frame: Up to 4 years ]

Locations (80)

Find similar trials in Yuma, AZ

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