Niraparib In The Treatment Of Patients With Advanced PALB2 Mutated Tumors

Study Overview

Niraparib in the Treatment of Patients with Advanced PALB2 Mutated Tumors

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.

N/A

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

DRUG: Niraparib

TMPS-101
IND Number: 159142 (OTHER Identifier) (OTHER: FDA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-12-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-09-26
First Submitted that Met QC Criteria 2021-12-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-01
First Posted (ACTUAL) 2021-12-27	Results First Posted N/A	Last Verified 2024-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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.

Participant Group/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.

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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
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
Overall Response Rate (ORR) - Investigator	To evaluate ORR as assessed by Investigator using RECIST v1.1	Up to 4 years
Duration of Response (DOR) - Investigator	To evaluate DOR as assessed by Investigator using RECIST v1.1	Up to 4 years
Progression-Free Survival (PFS) - Investigator	To evaluate PFS as assessed by Investigator using RECIST v1.1	Up to 4 years
Clinical Benefit Rate (CBR) - Investigator and ICR	To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator	Up to 4 years
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
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
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
Overall Survival (OS)	To evaluate overall survival (OS)	Up to 4 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

GlaxoSmithKline

Investigators

STUDY_DIRECTOR: Virginia Rhodes, Tempus AI, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record