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Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05169437
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : September 28, 2022
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Tempus Labs

Brief 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.

Condition or disease Intervention/treatment Phase
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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients With PALB2 Mutations
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2025


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.
Other Name: Zejula




Primary Outcome Measures :
  1. Overall Response Rate (ORR) - Independent Central Review (ICR) [ Time Frame: Up to 4 years ]
    To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1


Secondary Outcome Measures :
  1. Duration of Response (DOR) - Independent Central Review (ICR) [ Time Frame: Up to 4 years ]
    To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1

  2. Progression-Free Survival (PFS) - Independent Central Review (ICR) [ Time Frame: Up to 4 years ]
    To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  3. Overall Response Rate (ORR) - Investigator [ Time Frame: Up to 4 years ]
    To evaluate ORR as assessed by Investigator using RECIST v1.1

  4. Duration of Response (DOR) - Investigator [ Time Frame: Up to 4 years ]
    To evaluate DOR as assessed by Investigator using RECIST v1.1

  5. Progression-Free Survival (PFS) - Investigator [ Time Frame: Up to 4 years ]
    To evaluate PFS as assessed by Investigator using RECIST v1.1

  6. Clinical Benefit Rate (CBR) - Investigator and ICR [ Time Frame: Up to 4 years ]
    To evaluate Clinical Benefit Rate (CBR) as assessed by ICR and Investigator

  7. ORR with untreated measurable CNS lesions - Investigator [ Time Frame: Up to 4 years ]
    To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1

  8. ORR with untreated measurable CNS lesions - ICR [ Time Frame: Up to 4 years ]
    To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1

  9. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Up to 4 years ]
    To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)

  10. Overall Survival (OS) [ Time Frame: Up to 4 years ]
    To evaluate overall survival (OS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05169437


Contacts
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Contact: Brad Johnson (630)687-5723 pavo@tempus.com
Contact: Anjali Avadhani, MD pavo@tempus.com

Locations
Show Show 70 study locations
Sponsors and Collaborators
Tempus Labs
GlaxoSmithKline
Investigators
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Study Director: Anjali Avadhani, MD Tempus Labs, Inc.
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Responsible Party: Tempus Labs
ClinicalTrials.gov Identifier: NCT05169437    
Other Study ID Numbers: TMPS-101
IND Number: 159142 ( Other Identifier: FDA )
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tempus Labs:
PALB2
Solid Tumor
Metastatic Solid Tumor
Locally Advanced Solid Tumor
Advanced Solid Tumor
Local Solid Tumor
PALB2 Mutation
Niraparib
tPALB2
tPALB2 Mutation
Pathogenic tumor
Lung Tumor
Breast Tumor
Colon Tumor
Zejula
Pancreatic Cancer
Urologic Cancer
Melanoma
Metastatic Cancer
Head and Neck Cancer
Endometrial Cancer
Esophageal Cancer
Additional relevant MeSH terms:
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Neoplasms
Melanoma
Pancreatic Neoplasms
Head and Neck Neoplasms
Esophageal Neoplasms
Endometrial Neoplasms
Neoplasm Metastasis
Breast Neoplasms
Lung Neoplasms
Colonic Neoplasms
Urologic Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases