Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05169437
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tempus Labs
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Anjali Avadhani, MD
Principal Investigator Affiliation	Tempus Labs, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Arms & Interventions

Arms

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

Interventions

Drug: - Niraparib

Eligible participants will receive daily dosing of Niraparib.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yuma Regional Medical Center, Yuma, Arizona

Status

Recruiting

Address

Yuma Regional Medical Center

Yuma, Arizona, 85364

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