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Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
Phase 2 trial testing Niraparib in Solid Tumor in 22 participants. Terminated before completion.
| Lead sponsor | Tempus AI |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 15 March 2022 |
| Primary completion | 6 August 2024 |
| Estimated completion | 27 August 2024 |
| Sites | 80 locations across United States |
Tempus AI — full company profile →
18 and older, any sex, with Solid Tumor or Breast Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To evaluate overall response rate (ORR) as assessed by Independent Central Review (ICR) using RECIST v1.1
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 0 |
To evaluate duration of response (DOR) as assessed by ICR using RECIST v1.1
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 0 |
To evaluate progression-free survival (PFS) as assessed by ICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 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).
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 0 | |
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 2 | |
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 5 | |
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 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.
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | NA | NA – 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.
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 3.3 | 1.7 – 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).
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 6 | 21.1 – 78.9 |
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by Investigator using RECIST v1.1
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 0 |
To evaluate intracranial ORR in participants with untreated measurable CNS lesions as assessed by ICR using RECIST v1.1
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 0 |
To evaluate safety and tolerability per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 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.
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 81.8 | 44.7 – 95.1 |
| Group | Value | 95% CI |
|---|---|---|
| Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations | 51.9 | 19.8 – 76.7 |
Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Niraparib in Locally Advan… |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Haematochezia | Gastrointestinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Multiple organ dysfunction syndrome | General disorders | — |
| Sepsis | Infections and infestations | — |
| Acidosis | Metabolism and nutrition disorders | — |
| Seizure | Nervous system disorders | — |
| Hypotension | Vascular disorders | — |
| Reaction | System | Niraparib in Locally Advan… |
|---|---|---|
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Insomnia | Psychiatric disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Platelet count decreased | Investigations | — |
| Dizziness | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Hypertension | Vascular disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Blood creatinine increased | Investigations | — |
| Anxiety | Psychiatric disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Tachycardia | Cardiac disorders | — |
| Abdominal pain lower | Gastrointestinal disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Weight Decreased | Investigations | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — |
| Skin lesion | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Anaemia, Ascites, Haematochezia, Pleural effusion, Respiratory failure, Multiple organ dysfunction syndrome, Sepsis, Acidosis.
Data from ClinicalTrials.gov NCT05169437 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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