A Phase 2 interventional study of Niraparib in Solid Tumor, Breast Tumor and Colon Tumor, Malignant, sponsored by Tempus AI. Terminated at 80 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-29.
Sponsored by Tempus AI · Phase 2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 22 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tempus AI is the lead sponsor of 14 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Niraparib
Eligible participants will receive daily dosing of Niraparib.
Also known as: Zejula
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
Time frame: Up to 4 years
Duration of Response (DOR) - Independent Central Review (ICR)
To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1
Time frame: 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)
Time frame: Up to 4 years
Overall Response Rate (ORR) - Investigator
To evaluate ORR as defined as the proportion of patients who had a partial or complete response (PR or CR) to therapy, as assessed by Investigator using RECIST v1.1 and assessed periodically throughout the treatment period based on imaging every 8 weeks (56 ± 7 days).
Time frame: 2 years 3 months
Duration of Response (DOR) - Investigator
To evaluate DOR as assessed by Investigator using RECIST v1.1 defined as from first documentation of objective tumor response (CR or PR) to first documentation of objective tumor progression or death due to any cause.
Time frame: 2 years 3 months
Progression-Free Survival (PFS) - Investigator
To evaluate PFS as assessed by Investigator using RECIST v1.1 determined from the first dose to the date of first radiographic progression or death from any cause in the absence of progression, whichever occurred first, or were censored.
Time frame: 2 years 3 months
Clinical Benefit Rate (CBR) - Investigator and ICR
To evaluate Clinical Benefit Rate (CBR), defined as the percentage of patients who had achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for 8 weeks or more, as assessed by Investigator only (ICR not performed due to early study termination).
Time frame: 2 years 3 months
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
Time frame: 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
Time frame: Up to 4 years
Number of Participants With Treatment-Emergent Adverse Events
To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Time frame: 2 years 3 months
Overall Survival (OS)
To evaluate overall survival (OS) defined as the time from the date of first dose of study drug to the date of death by any cause. Patients who were alive were censored at the date of last contact.
Time frame: 6 months and 12 months
| Milestone | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Started | 22 |
| Completed | 16 |
| Not completed | 6 |
To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1
| Participants | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Overall Response Rate (ORR) - Independent Central Review (ICR) | 0 |
To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1
| Participants | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Duration of Response (DOR) - Independent Central Review (ICR) | 0 |
To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
| Participants | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Progression-Free Survival (PFS) - Independent Central Review (ICR) | 0 |
To evaluate ORR as defined as the proportion of patients who had a partial or complete response (PR or CR) to therapy, as assessed by Investigator using RECIST v1.1 and assessed periodically throughout the treatment period based on imaging every 8 weeks (56 ± 7 days).
| Participants | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Complete Response (CR) | 0 |
| Partial Response (PR) | 2 |
| Stable Disease (SD) | 5 |
| Progressive Disease (PD) | 5 |
To evaluate DOR as assessed by Investigator using RECIST v1.1 defined as from first documentation of objective tumor response (CR or PR) to first documentation of objective tumor progression or death due to any cause.
| Months | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Duration of Response (DOR) - Investigator | NA (NA to NA) |
To evaluate PFS as assessed by Investigator using RECIST v1.1 determined from the first dose to the date of first radiographic progression or death from any cause in the absence of progression, whichever occurred first, or were censored.
| Months | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Progression-Free Survival (PFS) - Investigator | 3.3 (1.7 to NA) |
To evaluate Clinical Benefit Rate (CBR), defined as the percentage of patients who had achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for 8 weeks or more, as assessed by Investigator only (ICR not performed due to early study termination).
| Participants | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Clinical Benefit Rate (CBR) - Investigator and ICR | 6 (21.1 to 78.9) |
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1
| Participants | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| ORR With Untreated Measurable CNS Lesions - Investigator | 0 |
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1
| Participants | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| ORR With Untreated Measurable CNS Lesions - ICR | 0 |
To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
| Participants | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | 22 |
To evaluate overall survival (OS) defined as the time from the date of first dose of study drug to the date of death by any cause. Patients who were alive were censored at the date of last contact.
| Percentage | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Overall Survival at 6 Months | 81.8 (44.7 to 95.1) |
| Overall Survival at 12 Months | 51.9 (19.8 to 76.7) |
Collected over All adverse events (AEs) and serious adverse events (SAEs) were collected and recorded for each patient from the day of signing the main study informed consent form until 30 days after the last dose of study treatment up to 28 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 1/22 (4.5%) | 6/22 (27.3%) | 22/22 (100%) |
| Event | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/22 |
| AscitesGastrointestinal disorders | 1/22 |
| HaematocheziaGastrointestinal disorders | 1/22 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/22 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/22 |
| Multiple organ dysfunction syndromeGeneral disorders | 1/22 |
| SepsisInfections and infestations | 1/22 |
| AcidosisMetabolism and nutrition disorders | 1/22 |
| SeizureNervous system disorders | 1/22 |
| HypotensionVascular disorders | 1/22 |
| Event | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| NauseaGastrointestinal disorders | 10/22 |
| FatigueGeneral disorders | 10/22 |
| InsomniaPsychiatric disorders | 8/22 |
| AnaemiaBlood and lymphatic system disorders | 7/22 |
| Decreased appetiteMetabolism and nutrition disorders | 6/22 |
| DehydrationMetabolism and nutrition disorders | 6/22 |
| ConstipationGastrointestinal disorders | 5/22 |
| Platelet count decreasedInvestigations | 5/22 |
| DizzinessNervous system disorders | 5/22 |
| HeadacheNervous system disorders | 5/22 |
| Age, Categorical(Participants) | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 16 |
| Sex: Female, Male(Participants) | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Female | 15 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Ethnicity (NIH/OMB)(Participants) | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Baseline Height(cm) | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Mean | 166.5 ± 10.31 |
| Baseline Weight(kg) | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Mean | 74.46 ± 19.663 |
| Baseline ECOG Performance Status(Participants) | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| ECOG 0 | 7 |
| ECOG 1 | 15 |
| Cancer Type(Participants) | Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations |
|---|---|
| Colon Cancer | 4 |
| Pancreatic Carcinoma | 4 |
| Breast Cancer | 3 |
| Gastric Cancer | 2 |
| Bile Duct Cancer | 1 |
| Endometrial Cancer | 1 |
| Glioma | 1 |
| Malignant Melanoma | 1 |
| Neuroendocrine Carcinoma | 1 |
| Non-Small Cell Lung Cancer | 1 |
| Renal Cancer | 1 |
| Sarcoma | 1 |
| Uterine Cancer | 1 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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