[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"homologous-recombination-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:homologous-recombination-deficiency":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,71,94,118,160],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100636397","phase-2-lorigerlimab-mgd019-in-patients-with-pancreatic-adenocarcinoma-and-homologous-recombination-deficiency-100636397",false,"NCT07565155","Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency","A Phase 2 Trial of Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency","Inclusion Criteria:\n\n1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.\n2. ≥ 18 years of age.\n3. Histologically confirmed pancreas carcinoma with metastatic disease. Neuroendocrine neoplasms are not eligible. Adenosquamous, squamous and acinar histologies are allowed provided criteria #5 is fulfilled, and these histologies comprise no more than 10% of the total accrual.\n4. Measurable disease on baseline imaging by CT (or MRI where CT is contraindicated) based on RECIST 1.1.\n5. Documented germline mutation in BRCA1, BRCA2, PALB2, radiation sensitive protein 51 C (RAD51C), or radiation sensitive protein 51 D (RAD51D) that is known or predicted to be detrimental or lead to loss of function on a chemiluminescence immunoassay (CLIA)-approved assay (e.g. Invitae, Ambry, Myriad, Tempus).\n6. Must have an accessible tumor amenable to a safe biopsy where the major complication rate is ≤ 1.5% in the judgement of the investigator.\n7. Must have prior exposure and disease progression after at least one line of platinum-based chemotherapy. Platinum-based chemotherapy given in the neo-adjuvant or adjuvant setting also satisfies this requirement if progression occurs within 1 year of the end of adjuvant therapy.\n8. Prior receipt of a poly (ADP-ribose) polymerase (PARP) inhibitor is allowed but not mandatory.\n9. Life expectancy of at least 3 months.\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n11. Adequate organ function defined as the following laboratory values within 14 days of Cycle 1 Day 1:\n\n    1. Neutrophils \\>1000\u002FμL (stable off any growth factor within 4 weeks of first study treatment administration).\n    2. Platelets \\> 100 × 103\u002FμL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).\n    3. Hemoglobin \\> 8.0 g\u002FdL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).\n    4. Serum creatinine \\\u003C 1.5 × upper limit of normal (ULN), or creatinine clearance ≥30 mL\u002Fmin (measured or calculated using Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)).\n    5. Aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) \\\u003C 3.0 × ULN or \\\u003C 5.0 x ULN if liver metastases are present.\n    6. Total bilirubin \\\u003C 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of \\\u003C 3.0 × ULN).\n    7. Albumin ≥ 3.0 g\u002FdL.\n12. Female patients of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) with repeat urine or serum pregnancy test of Day 1 of each cycle and at the end of treatment visit. Nonchildbearing potential is defined as: a. ≥ 50 years of age and has not had menses for greater than 1 year. b. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation. c. Status is post hysterectomy, bilateral oophorectomy, or tubal ligation. d. Female patients who are diagnosed with a tumor that is known to secrete human chorionic gonadotropin (HCG) must be certified not pregnant based on clinical evidence and investigator judgment.\n13. Female patients of child-bearing potential must agree to use highly effective contraceptive measures starting with the screening visit through 7 months after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n14. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 7 months after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n15. Willing and able to comply with the requirements of the protocol.\n\nExclusion Criteria:\n\n1. Has received any prior therapy with an anti-PD-1\u002FPD-L1 antibody or an anti-cytotoxic T lymphocyte-associated (CTLA) protein 4 (anti-CTLA-4) antibody.\n2. Has clinically significant ascites defined as requiring 1 or more therapeutic paracenteses in the last 4 weeks prior to study entry.\n3. Grade 2 or higher peripheral neuropathy\n4. Clinically significant gastrointestinal disorders including:\n\n   1. Any history of gastrointestinal perforation unless the affected area has been deemed by the investigator to no longer be a risk for perforation.\n   2. History of clinically significant gastrointestinal bleeding within 4 weeks prior to initiation of study treatment.\n   3. History of acute pancreatitis within 4 weeks prior to the initiation of study treatment.\n   4. Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and\u002For the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study treatment administration.\n   5. Bowel obstruction or impending bowel obstruction within the past 3 months.\n5. Clinically significant (i.e. active) cardiovascular disease:\n\n   1. Cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n   2. Pericarditis or clinically significant pericardial effusion.\n   3. Any history of myocarditis.\n6. Known central nervous system (CNS) involvement as follows: a. Untreated CNS metastases. b. Leptomeningeal metastases. c. NOTE: Patients may be eligible if CNS metastases have been treated and patients have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment).\n7. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of study treatment (i.e. patients with a history of prior malignancy are eligible if treatment was completed at least 1 year before the first dose of study treatment and the patient has no evidence of disease). Patients with history of prior early-stage basal\u002Fsquamous cell skin cancer or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.\n8. Washout period prior to Cycle 1 Day1: Participants must recover from clinically significant adverse events from their more recent therapy or intervention prior to study enrollment.\n\n   No specific time windows are given.\n9. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n10. Symptomatic interstitial lung disease (ILD) or ILD which may interfere with detection and management of new immune-related pulmonary toxicity.\n11. History of allogeneic solid organ or stem cell transplant.\n12. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n13. Patients with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent), are permitted in the absence of active autoimmune disease.\n14. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e. with use of disease modifying agents or immunosuppressive drugs). Replacement therapy with thyroxine, insulin or physiologic corticosteroid replacement therapy is not considered systemic treatment for autoimmune disease.\n15. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n16. Breastfeeding patients.\n17. Note: All patients diagnosed with disease known to secrete HCG will test positive for pregnancy. Therefore, a positive pregnancy test is not exclusion criteria for these patients.\n\n    However, pregnancy negative status must be otherwise reasonably ascertained by other objective means.\n18. Active infection requiring treatment within 2 weeks of Cycle 1 Day1.\n19. HIV positive, except cluster of differentiation 4 (CD4) \\>200 and HIV viral load undetectable.\n20. Active hepatitis B or C infection:\n21. Patients with hepatitis B virus (HBV) infection are eligible if hepatitis B surface antigen and HBV DNA are negative.\n22. Patients with hepatitis C virus (HCV) infection are eligible if HCV RNA is negative.\n23. Participants with impaired decision-making capacity","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to determine the objective response rate (ORR) to lorigerlimab in patients with refractory pancreatic ductal adenocarcinoma (PDAC) and pathogenic germline variants (PGVs) in breast cancer type 1 or 2 susceptibility protein (BRCA1\u002F2), Partner and Localizer of BRCA2 (PALB2) and radiation sensitive protein 51 C or D (RAD51C\u002FD).",[26,27],"Pancreatic Adenocarcinoma","Homologous Recombination Deficiency","NOT_YET_RECRUITING","2026-04-27",{"date":31,"type":32},"2026-05-04","ACTUAL",{"date":34,"type":20},"2026-06-01",{"date":36,"type":20},"2031-06-01",{"name":38,"class":39},"Peter Hosein, MD","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100325826","phase-2-bipolar-androgen-therapy--carboplatin-in-mcrpc-100325826","NCT03522064","Bipolar Androgen Therapy + Carboplatin in mCRPC","High Dose Testosterone + Carboplatin in Men With Advanced Prostate Cancer","HiTeCH","Inclusion Criteria:\n\n1. Males with histologically confirmed adenocarcinoma of the prostate\n2. Confirmed HRD (Homologous recombination defect) in germline and\u002For somatic DNA analysis (tumour or blood), by a validated assay (see Appendix 1). Mutations in HR genes not listed in appendix 1 will be considered in literature suggests pathogenicity. A maximum of 10 uncharacterised or heterozygous mutations will be included.\n3. Age ≥ 18 years\n4. ECOG performance status ≤ 1\n5. Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug\u002FL despite castrate levels of testosterone\n6. Serum testosterone \\\u003C 1.7 nmol\u002FL and on an LHRH agent or post orchidectomy ≥ 1 year.\n7. Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent)\n8. Adequate bone marrow function (platelets \\> 100 x 109\u002FL, ANC \\> 1.5 x 109\u002FL, Hb \\>100)\n9. Adequate liver function (ALT\u002FAST \\\u003C 1.5 x ULN, bilirubin \\\u003C 2 x ULN)\n10. Adequate renal function (creatinine clearance \\> 50 ml\u002Fmin)\n11. Adequate cardiac function and reserve after cardiology assessment\n12. Archived tissue sample available or willingness to undergo fresh biopsy\n13. Willing and able to comply with all study requirements, including treatment, timing and\u002For nature of required assessments\n14. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Contraindications to investigational product\n2. Pain due to metastatic prostate cancer requiring opioid analgesics\n3. Evidence of disease progression in sites or extent that, in the opinion of the investigator, would put the patient at risk from testosterone therapy and its potential for initial tumour flare (eg: femoral metastasis at risk of fracture, ureteric obstruction due to nodal disease or cord compression due to spinal metastases).\n4. Previous treatment with platinum chemotherapy and\u002For a PARP inhibitor. However up to 8 men with prior treatment to these agents will be included as an exploratory cohort.\n5. Life expectancy of less than 3 months.\n6. Brain metastases or leptomeningeal disease\n7. History of thromboembolic event and not currently on anticoagulation\n8. Prior myocardial infarction or unstable angina within 2 years of study entry\n9. Haematocrit ≥ 50%, untreated severe obstructive sleep apnoea or poorly controlled heart failure (NYHA \\>1)\n10. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.\n11. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.\n12. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.","MALE",{"count":51,"type":20},30,[23],"The purpose of this study is to determine the efficacy of BAT and carboplatin in men with metastatic castrate-resistant prostate cancer (mCRPC).",[55,27],"Castration-resistant Prostate Cancer",[57,58,59,60],"Castrate-resistant prostate cancer","bipolar androgen therapy","homologous recombination deficiency","BRCA","RECRUITING","2026-04-22",{"date":64,"type":32},"2026-04-23",{"date":66,"type":32},"2018-07-30",{"date":68,"type":20},"2027-12-30",{"name":70,"class":39},"St Vincent's Hospital, Sydney",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":40},"100523396","phase-2-cisplatin-to-patients-with-pancreatic-cancer-and-homologous-recombination-deficiency-100523396","NCT06095141","Cisplatin to Patients With Pancreatic Cancer and Homologous Recombination Deficiency","Cisplatin Based Regimen to Patients With Advanced Pancreatic Cancer and Homologous Recombination Deficiency","PTCA199-6","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document.\n* Age ≥ 18 years and ≤ 80 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Histologically or cytologically confirmed advanced pancreas adenocarcinoma.\n* Tumor progression after at least one line of chemotherapy.\n* Genetic or molecular test confirmed the presence of homologous recombination deficiency.\n* Presence of at least of one measurable lesion in agreement to RECIST criteria.\n* The expected survival ≥ 3 months.\n* Adequate organ performance based on laboratory blood tests.\n* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Primary pancreatic cancer.\n* Patients who have received platinum or PARPi treatment.\n* The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.\n* Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.\n* Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.\n* Renal insufficiency or dialysis\n* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.\n* Patients who are allergic to cisplatin or other platinum drugs.\n* Patients who are unwilling or unable to comply with study procedures.","80 Years",{"count":51,"type":20},[23,82],"PHASE3","The purpose of this study is to evaluate the efficacy of cisplatin based regimen to patients with advanced pancreatic cancer and homologous recombination deficiency.",[26,27],"2025-08-04",{"date":87,"type":32},"2025-08-07",{"date":89,"type":32},"2023-12-01",{"date":91,"type":20},"2026-10-31",{"name":93,"class":39},"Fudan University",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":40},"100402098","phase-2-olaparib-in-patients-with-hrd-malignant-mesothelioma-100402098","NCT04515836","Olaparib in Patients With HRD Malignant Mesothelioma","Phase II Trial of Olaparib in Homologous Recombination Deficient (HRD) Malignant Mesothelioma","Inclusion Criteria:\n\n* Must have a medical diagnosis of malignant mesothelioma that has been confirmed by a physician.\n* Participant must be able to sign a consent form stating that they choose (of their own free will) to participate in the study and agree to follow the study requirements and restrictions that are listed in the consent form.\n* Must be willing to sign and date consent form before any mandatory study-specific procedures, sample collecting and tests.\n* Willing to experience genetic testing to determine study eligibility. Must be willing to genetically test tumor and normal body cells.\n* Before participating in the treatment phase of this study, participants must be willing to give their own consent (agreement) to have their samples collected for genetic and biomarker research.\n* Age 18 or older.\n* Participant must show evidence of specific DNA changes\u002Fgenetic mutations defined as follows: A) BAP1 loss (the loss of a protein called ubiquitin carboxyl-terminal hydrolase) verified by physicians at the University of Chicago using sampling tests AND\u002FOR B) A mutation (abnormal change) in the participant's germ cells (reproductive cells) or somatic cells (non-reproductive cells) that disrupts protein function in at least one of the patient's genes.\n* Prior treatment with cisplatin or carboplatin is required.\n* Patients must have platinum-sensitive disease (cancer that responds to treatments with anticancer drugs containing metal platinum). For eligibility in this study, platinum-sensitive disease will be defined as no disease progression while on a platinum agent (chemotherapy drug) or for at least 3 months after completing treatment with a platinum agent.\n* Patients must have normal organ and bone marrow function measured within 28 days prior to receiving study treatment. Normal bone marrow and organ function will be assessed using specific lab tests\u002F criteria set by the study's lead physician.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Patients must have a life expectancy of 16 weeks or more.\n* Must have a tumor that can be measured according to criteria set by the modified Response Evaluation Criteria in Solid Tumors (RECIST) standards for pleural mesothelioma and RECIST 1.1 for peritoneal and tunica vaginalis mesothelioma. Patients in the study must have at least one area of damaged tissue (a lesion) that has not received previous radiation treatment. This damaged tissue must be accurately measured at the beginning of the study as greater than or equal to 10 mm in the longest diameter (except lymph nodes which must have short axis greater than or equal to 15 mm). The patient's tumor would be measured using computed tomography (CT), which is suitable for accurate repeated measurements.\n* Both male and female patients can participate in this study.\n* If a woman is of childbearing potential and wishes to participate in the study, she most show evidence that she is not pregnant using a negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.\n* Women who are postmenopausal and wish to participate in the study, must also show evidence of postmenopausal status. Postmenopausal status will be defined as: 1) A woman who does not experience menstruation (known as amenorrhea) for 1 year or more following the end of hormonal treatments. 2) Women who have reproductive\u002Fhormone levels in the post-menopausal range for women under 50 as confirmed by medical tests; 3) Radiation-induced oophorectomy (removal of one or more ovaries) with last menses greater than 1 year ago; 4) Menopause caused by chemotherapy with greater than 1 year since last menses 5) Surgical sterilization (bilateral oophorectomy or hysterectomy).\n* Male patients must use a condom during treatment and for 3 months after the last dose of study drug (olaparib) when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.\n* NOTE 1: Tests to confirm the eligibility of participants who have the above mutations (altered germ or somatic cells) will take place at a germline or tumor sequencing lab that is certified under the Clinical Laboratory Improvement Amendments (CLIA). Eligibility of study participants will be confirmed once the physical leading this study receives the official mutation report from the lab and confirms that the participant's identified mutation fits the definition outlined above. All other patients must consent to tumor and normal sample sequencing as described in study procedures below during the prescreening phase to determine eligibility.\n* NOTE 2: Rare exceptions of participants who may have conflicting evidence regarding protein function will be interpreted on an individual basis by the physician leading the study.\n\nExclusion criteria:\n\nMedical conditions:\n\n* Any evidence of uncontrollable illness that the physician leading this study deems undesirable for the patient to participate in the trial.\n* Other malignancy (tumor\u002Fcancer) unless it has been treated with no evidence of disease for 3 or more years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.\n* Patients with BAP1 tumor predisposition syndrome will be included in the trial. These patients may be eligible if they have a history of syndrome-related cancers, provided they completed their surgery and chemotherapy more than three years prior to registration, and the patient remains free of disease that continues to re-occur or spread to other parts of the body.\n* Patients with cancer that does not respond to platinum chemotherapy drugs (known as platinum-resistant disease), defined as disease progression during or within 3 months of receiving chemotherapy.\n* Resting electrocardiogram (ECG) that shows the patient has uncontrolled, potentially reversible cardiac conditions or patients with congenital long QT syndrome (a heart rhythm condition that can cause fast, chaotic heartbeats), as judged by the study's lead physician.\n* Persistent toxicities (greater than the Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.\n* Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with findings suggestive of MDS\u002FAML.\n* Patients with cancer cells that have moved from one part of their body to the brain (brain metastases) causing the patient to show symptoms\u002Fsigns of more serious illness. A scan to confirm the absence of cancerous cells in the brain is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.\n* Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-cancerous systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n* Patients unable to swallow oral medications and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Patients who have a compromised immune system, e.g., patients who have tested positive for human immunodeficiency virus (HIV).\n* Patients with known active hepatitis (i.e. Hepatitis B or C) confirmed by medical tests; patients with a past or resolved Hepatitis B infection are eligible. Patients positive for hepatitis C virus are eligible only if samples of the patient's DNA tests negative for hepatitis C, according to genetic tests (using polymerase chain reaction).\n\nPrior\u002Fconcomitant therapy (medications\u002Ftreatments that may conflict with the study drug, olaparib):\n\n* Any previous treatment with a type of drug\u002Fsubstance called a PARP inhibitor (which stands for poly-ADP ribose polymerase inhibitor), including olaparib.\n* Receipt of any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.\n* Patients who are using strong cancer drugs called CYP3A inhibitors (also called Cytochrome P-450) for treatment (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). Any treatment previously taken by the patient must be washed out of the patient's system 2 weeks before taking olaparib in this study.\n* Patients who are using known strong CYP3A inducers (drugs for cancer patients including phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). Any patients taking enzalutamide must have the drug washed out of their system 5 weeks before stating olaparib in this study; patients taking phenobarbital and other agents must have the drug washed out of their system 3 weeks before taking olaparib in this study.\n* Major surgery within 2 weeks of starting study treatment; patients must have recovered from any effects of any major surgery.\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n\nPrior\u002Fconcurrent clinical study experience:\n\n* Participation in another clinical study where the patient received a study drug in the last month before starting this study.\n* Patients with a known hypersensitivity to olaparib or any of the ingredients in the product.\n\nOther exclusions:\n\n* Involvement in the planning and\u002For conduct of the study.\n* The lead study physician deciding that the patient should not participate in the study if the patient is unlikely to follow study procedures, restrictions and requirements.\n* Pregnant or breast-feeding women.",{"count":102,"type":20},56,[23],"In this study, researchers will give olaparib (a drug) to mesothelioma patients who have specific changes in their DNA (known as gene mutations). Researchers will give this drug to each patient on the study to find out if it will help the patient's tumor shrink or stop growing.",[106,27],"Mesothelioma",[108],"mesothelioma, lung cancer, malignant mesothelioma","2025-05-05",{"date":111,"type":32},"2025-05-06",{"date":113,"type":32},"2021-02-19",{"date":115,"type":20},"2028-04-15",{"name":117,"class":39},"University of Chicago",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":129,"conditions":130,"keywords":136,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":159},"100401132","phase-1-a-trial-of-amxi-5001-for-treatment-in-patients-with-advanced-malignancies-100401132","NCT04503265","A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies","A Phase I\u002FII, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies","Inclusion Criteria (Key Factors):\n\n1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:\n\n   1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition\n   2. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit\n   3. Malignancy has progressed after standard therapy\n2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological and\u002For laboratory assessments as applicable to their malignancy.\n3. Eastern Co-operative Oncology Group (ECOG) PS 0-1\n4. Participant must be 18 years of age or older\n5. Able to understand and sign consent\n\nExclusion Criteria (Key Factors):\n\n1. Receiving cancer treatment at the time of enrollment\n2. Any clinically significant disease or condition affecting a major organ system\n3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities\n4. Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)\n5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer",{"count":126,"type":20},122,[128,23],"PHASE1","ATLAS-101 is a Phase I\u002FII clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.",[131,132,133,27,134,135],"Advanced Malignant Neoplasm","Breast Cancer","Ovarian Cancer","Prostate Cancer","Pancreatic Cancer",[137,138,139,140,141,142,143,60,144,145,146,147,148],"Breast","Ovarian","Prostate","Pancreatic","Refractory","Cancer","Malignancy","HRD","AMXI-5001","Progression","PARP Inhibitor","Microtubule inhibitor","2025-04-29",{"date":151,"type":32},"2025-05-01",{"date":153,"type":32},"2020-08-12",{"date":155,"type":20},"2026-10",{"name":157,"class":158},"AtlasMedx, Incorporated","INDUSTRY",4,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":40},"100556453","phase-1-eis-12656-as-single-agent-and-in-combination-in-patients-with-specified-solid-tumors-100556453","NCT06525298","EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors","A Phase 1\u002F2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors","Inclusion Criteria:\n\n* Recurrent locally advanced or metastatic solid tumors\n* Homologous recombination deficient mutations\n* Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy\n* Measurable disease (RECIST 1.1 Criteria)\n* Adequate organ and bone marrow function\n* ECOG Performance Status 0 or 1\n* Life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* History or evidence of any clinically relevant gastrointestinal disease\n* Radiation therapy within ≤2 weeks\n* Significant cardiovascular disease\n* Uncontrolled, active, symptomatic brain metastases",{"count":168,"type":20},144,[128,23],"This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).",[172,27,173],"Advanced Solid Tumor","HRR Deficiency","2024-09-14",{"date":176,"type":32},"2024-09-19",{"date":178,"type":32},"2024-09-09",{"date":180,"type":20},"2027-12",{"name":182,"class":158},"Eisbach Bio GmbH"]