Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    110
  • sponsor
    Tempus Labs
Updated on 24 May 2022
corticosteroid
solid tumor
palb2
formalin-fixed paraffin-embedded

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.

Details
Condition 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
Treatment Niraparib
Clinical Study IdentifierNCT05169437
SponsorTempus Labs
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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