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Gene Symbol | PALB2 | ||||||||||
Synonyms | BROVCA5 | FANCN | PNCA3 | ||||||||||
Gene Description | PALB2, partner and localizer of BRCA2, recruits Brca2 and Rad51 to repair DNA through homologous recombination (PMID: 24998779, PMID: 30638972). PALB2 loss of function mutations have been linked to hereditary breast cancer (PMID: 25135369) and male breast cancer (PMID: 31067289). | ||||||||||
ACMG Incidental List v3.0: |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT03840967 | Phase II | Niraparib | A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma | Active, not recruiting | USA | 0 |
NCT05174455 | Phase II | Niraparib | Niraparib for the Treatment of Leiomyosarcoma | Withdrawn | 0 | |
NCT03413995 | Phase II | Rucaparib | Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH) | Active, not recruiting | USA | 0 |
NCT06177171 | Phase I | Decitabine and Cedazuridine + Olaparib | Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors | Not yet recruiting | USA | 0 |
NCT03337087 | Phase Ib/II | Fluorouracil + Leucovorin + Liposomal irinotecan + Rucaparib | Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer | Active, not recruiting | USA | 0 |
NCT04992013 | Phase II | Niraparib | Niraparib in Tumors Metastatic to the CNS | Recruiting | USA | 0 |
NCT03432897 | Phase II | Olaparib | BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes (337) | Terminated | USA | 0 |
NCT02950064 | Phase I | BTP-114 | A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations | Unknown status | USA | 0 |
NCT03533946 | Phase II | Rucaparib | Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR) | Terminated | USA | 0 |
NCT03061188 | Phase I | Nivolumab + Veliparib | Nivolumab and Veliparib in Treating Patients With Recurrent or Refractory Stage IV Solid Tumors That Cannot Be Removed by Surgery or Lymphoma With or Without Alterations in DNA Repair Genes | Unknown status | USA | 0 |
NCT04052555 | Phase I | Berzosertib | Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer | Active, not recruiting | USA | 0 |
NCT03207347 | Phase II | Niraparib | A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) | Completed | USA | 0 |
NCT04288687 | Phase II | Niraparib | A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects | Active, not recruiting | USA | 0 |
NCT03924245 | Phase Ib/II | Entinostat Entinostat + Olaparib | Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers | Terminated | USA | 0 |
NCT03375307 | Phase II | Olaparib | Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes | Recruiting | USA | 0 |
NCT05203445 | Phase II | Olaparib + Pembrolizumab | A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer | Recruiting | USA | 0 |
NCT02693535 | Phase II | Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) | Recruiting | USA | 0 |
NCT03448718 | Phase II | Olaparib | Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations | Completed | USA | 0 |
NCT03432676 | Phase II | Epacadostat + Pembrolizumab | Study of IDO-1 Inhibitor Epacadostat in Combination With Pembrolizumab in Advanced Pancreatic Cancer With Chromosomal Instability/ Homologous Recombination Repair Deficiency (HRD) | Withdrawn | 0 | |
NCT04197713 | Phase I | Adavosertib + Olaparib | Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study | Active, not recruiting | USA | 0 |
NCT05986071 | Phase Ib/II | Fulvestrant + M1774 | I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers (MATRIX) | Not yet recruiting | FRA | 0 |
NCT01585805 | Phase II | Veliparib Cisplatin + Gemcitabine | Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer | Active, not recruiting | USA | CAN | 1 |
NCT04633902 | Phase II | Olaparib + Pembrolizumab | Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation | Recruiting | USA | 0 |
NCT04042831 | Phase II | Olaparib | Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations | Recruiting | USA | 0 |
NCT03601923 | Phase II | Niraparib | Niraparib in Patients With Pancreatic Cancer | Active, not recruiting | USA | 0 |
NCT05659914 | Phase II | Durvalumab + Olaparib | Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations | Recruiting | ESP | 0 |
NCT03718091 | Phase II | Berzosertib | M6620 (VX-970) in Selected Solid Tumors | Completed | USA | 0 |
NCT02286687 | Phase II | Talazoparib | Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes | Active, not recruiting | USA | 0 |
NCT03012321 | Phase II | Abiraterone + Olaparib + Prednisone Abiraterone + Prednisone Olaparib | Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects | Active, not recruiting | USA | 0 |
NCT04187833 | Phase II | Nivolumab + Talazoparib | Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes | Completed | USA | 0 |
NCT02476968 | FDA approved | Olaparib | To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer (ORZORA) | Completed | ITA | GBR | ESP | CAN | 4 |
NCT04586335 | Phase I | CYH33 + Olaparib | Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. | Terminated | USA | AUS | 1 |
NCT03318445 | Phase I | Rucaparib Irinotecan + Rucaparib | Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair | Completed | USA | 0 |
NCT02029001 | Phase II | Durvalumab + Tremelimumab Olaparib Pazopanib Nilotinib | Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment (MOST plus) | Recruiting | FRA | 0 |
NCT04030559 | Phase II | Niraparib | Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects | Recruiting | USA | 0 |
NCT02873975 | Phase II | Prexasertib | A Study of LY2606368 (Prexasertib) in Patients With Solid Tumors With Replicative Stress or Homologous Repair Deficiency | Completed | USA | 0 |
NCT01489865 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Veliparib | ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer | Unknown status | USA | 0 |
NCT04038502 | Phase II | Olaparib Carboplatin | Carboplatin or Olaparib for BRcA Deficient Prostate Cancer (COBRA) | Recruiting | USA | 0 |
NCT03842228 | Phase I | Copanlisib + Durvalumab + Olaparib | Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations | Active, not recruiting | USA | 0 |
NCT04402073 | Phase II | Cisplatin + Lomustine + Vincristine Sulfate Cisplatin + Lomustine + Sonidegib + Vincristine Sulfate | Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (PersoMed-I) | Recruiting | NLD | ITA | FRA | ESP | DEU | AUT | AUS | 1 |
NCT05327010 | Phase II | Talazoparib + ZEN-3694 | Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial | Recruiting | USA | 0 |
NCT04826341 | Phase Ib/II | Berzosertib + Sacituzumab govitecan-hziy | A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors | Recruiting | USA | 0 |
NCT06201234 | Phase II | Niraparib Elacestrant + Niraparib | Evaluating the Addition of Elacestrant (Oral SERD) to Niraparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer (ELEMENT) | Not yet recruiting | DEU | 0 |
NCT05379972 | Phase II | Olaparib + Pembrolizumab | Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers | Recruiting | USA | 0 |
NCT06078787 | Phase II | Olaparib | Olaparib in PALB2 Advanced Pancreatic Cancer (PALBOLA) | Recruiting | ITA | 0 |
NCT05501548 | Phase II | Olaparib | Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer | Recruiting | USA | 0 |
NCT02925234 | Phase II | Palbociclib Ribociclib Lenvatinib Ipilimumab + Nivolumab Trametinib Crizotinib Niraparib Selpercatinib Olaparib Erlotinib Erdafitinib Dabrafenib Dacomitinib Rucaparib Axitinib Panitumumab Pemigatinib Durvalumab Afatinib Entrectinib Tepotinib Alpelisib Atezolizumab + Bevacizumab Alectinib Regorafenib Cobimetinib + Vemurafenib Nilotinib Vismodegib Abemaciclib Sunitinib Nivolumab Cabozantinib Lorlatinib Talazoparib Dabrafenib + Trametinib Pembrolizumab Pertuzumab + Trastuzumab | The Drug Rediscovery Protocol (DRUP Trial) (DRUP) | Recruiting | NLD | 0 |
NCT04171700 | Phase II | Rucaparib | A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR) | Terminated | USA | 0 |
NCT04858334 | Phase II | Olaparib | APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation | Recruiting | USA | 0 |
NCT06212583 | Phase II | Abiraterone + Niraparib | High-Risk Metachronous Oligometastatic Prostate Cancer Trial (KNIGHTS) | Recruiting | USA | 0 |
NCT03140670 | Phase II | Rucaparib | Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy | Terminated | USA | 0 |
NCT05417594 | Phase Ib/II | AZD9574 AZD9574 + Temozolomide | Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (CERTIS1) | Recruiting | USA | GBR | ESP | DEU | AUS | 2 |
NCT04985721 | Phase II | Pamiparib + Tislelizumab | A Trial of Pamiparib With Tislelizumab in Patients With Advanced Tumours With Homologous Recombination Repair Defects (IMPARP-HRD) | Recruiting | AUS | 0 |
NCT04053322 | Phase II | Durvalumab + Fulvestrant + Olaparib | Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF) | Active, not recruiting | FRA | 0 |
NCT02734004 | Phase Ib/II | Durvalumab + Olaparib Bevacizumab + Durvalumab + Olaparib | A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (MEDIOLA) | Active, not recruiting | USA | NLD | GBR | FRA | 3 |
NCT04266912 | Phase Ib/II | Avelumab + Berzosertib | Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors | Active, not recruiting | USA | 0 |
NCT04550494 | Phase II | Talazoparib | Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations | Recruiting | USA | 0 |
NCT03209401 | Phase I | Carboplatin + Niraparib | Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies | Terminated | USA | 0 |
NCT03570476 | Phase II | Olaparib | Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer | Terminated | USA | 0 |
NCT04983745 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) | Recruiting | USA | 0 |
NCT04276376 | Phase II | Atezolizumab + Rucaparib | Efficacy and Safety of the Combination of Rucaparib (PARP Inhibitor) and Atezolizumab (Anti-PD-L1 Antibody) in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors (ARIANES) | Suspended | FRA | 0 |
NCT04666740 | Phase II | Olaparib + Pembrolizumab | A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy | Recruiting | USA | 0 |
NCT03992131 | Phase Ib/II | Lucitanib + Rucaparib Rucaparib + Sacituzumab govitecan-hziy | A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR) | Terminated | USA | 0 |
NCT03810105 | Phase II | Durvalumab + Olaparib | A Study of Olaparib and Durvalumab in Prostate Cancer | Terminated | USA | 0 |
NCT05169437 | Phase II | Niraparib | Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors (PAVO) | Active, not recruiting | USA | 0 |
NCT04693468 | Phase I | Axitinib + Talazoparib Crizotinib + Talazoparib Palbociclib + Talazoparib | Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial | Recruiting | USA | 0 |
NCT05442749 | Phase II | Niraparib | Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer (PARPi-PANC) | Recruiting | FRA | 0 |
NCT05358639 | Phase I | Navitoclax + Olaparib | Combination of Olaparib and Navitoclax in Women With HGSC and TNBC | Recruiting | CAN | 0 |
NCT04779151 | Phase II | Dostarlimab-gxly + Niraparib | Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (NIRADO) | Suspended | FRA | 0 |
NCT04019327 | Phase Ib/II | Talazoparib + Temozolomide | A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer | Recruiting | USA | 0 |
NCT04756765 | Phase II | Talazoparib | Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer | Recruiting | USA | 0 |
NCT05338346 | Phase I | ATG-018 | A Study of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies (ATRIUM) | Recruiting | AUS | 0 |
NCT05694715 | Phase I | Irinotecan + Niraparib | Combination Therapy in Cancers With Mutations in DNA Repair Genes | Recruiting | USA | 0 |
NCT04890613 | Phase I | CX-5461 | Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation | Recruiting | USA | CAN | 0 |
NCT03786796 | Phase II | Olaparib | Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) | Recruiting | USA | 0 |
NCT04493060 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer | Active, not recruiting | USA | 0 |
NCT03344965 | Phase II | Olaparib | Olaparib In Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
NCT05700721 | Phase II | Dostarlimab-gxly + Niraparib | Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) | Recruiting | USA | 0 |
NCT05038839 | Phase I | Cabozantinib + Pamiparib | Cabozantinib and Pamiparib for the Treatment of Advanced of Refractory Solid Tumors | Recruiting | USA | 0 |
NCT05188508 | Phase II | Olaparib + Pembrolizumab + Temozolomide | Pembrolizumab, Olaparib, and Temozolomide for People With Glioma | Recruiting | USA | 0 |
NCT05340413 | Phase II | Olaparib | Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer. (RADIOLA) | Recruiting | ESP | 0 |
NCT03442556 | Phase II | Carboplatin + Docetaxel + Rucaparib | Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency | Active, not recruiting | USA | 0 |
NCT02401347 | Phase II | Talazoparib | Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors | Completed | USA | 0 |
NCT03377556 | Phase II | Talazoparib | Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer | Completed | USA | CAN | 0 |
NCT05033756 | Phase II | Olaparib + Pembrolizumab | Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency (COMPRENDO (COMPRENDO) | Recruiting | DEU | 0 |
NCT05071209 | Phase Ib/II | Elimusertib | Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors | Active, not recruiting | USA | CAN | 0 |
NCT04253262 | Phase Ib/II | Copanlisib + Rucaparib | A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer | Active, not recruiting | USA | 0 |
NCT05687110 | Phase I | Novobiocin | Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes | Recruiting | USA | 0 |
NCT05010096 | Phase I | Copanlisib + Elimusertib | BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors | Withdrawn | 0 | |
NCT04336943 | Phase II | Durvalumab + Olaparib | Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load | Active, not recruiting | USA | 0 |
NCT03047135 | Phase II | Olaparib | Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis | Active, not recruiting | USA | 0 |