[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-pancreatic-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-pancreatic-carcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100428384","phase-2-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-100428384",false,"NCT04858334","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","Inclusion Criteria:\n\n* STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA\n* Patient must be \\>= 18 years of age on day of consent\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator\n\n  * NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling\n* Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course)\n* Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery)\n* Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org\n* STEP 1 (RANDOMIZATION) INCLUSION CRITERIA\n* Patient must have met the eligibility criteria outlined above\n* Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course)\n* Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports\n* If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing\n* Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained =\\\u003C 4 weeks prior to Step 1 randomization\n* Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy\n* Patient must be \\>= 21 days (three weeks) from their last treatment (including chemotherapy radiotherapy or surgery) but =\\\u003C 84 days (twelve weeks) from their last treatment at the time of Step 1 randomization. Patients who have received neoadjuvant and\u002For adjuvant radiotherapy are eligible\n* Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities \\> grade 1 with the exception of alopecia and\u002For neuropathy)\n* Patient must not be receiving any other investigational agents at the time of Step 1 randomization and while on protocol treatment\n* Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib\n* Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML\n* Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib\n* Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment for female patients and for 3 months after the last dose of protocol treatment for male patients. Patients must also not donate sperm while on protocol treatment and for 3 months after the last dose of protocol treatment. Patients must also not breast-feed while on protocol treatment and for 1 month after the last dose of protocol treatment\n* Leukocytes \\>= 3,000\u002FmcL (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Platelets \\>= 100,000\u002FmcL (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Hemoglobin \\>= 9.0 g\u002FdL with no blood transfusion in the past 28 days (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Total bilirubin =\\\u003C 1.5 institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =\\\u003C 2.5 x ULN of the direct bilirubin (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Creatinine =\\\u003C 1.5 institutional ULN OR calculated Cockcroft Gault creatinine clearance \\> 50 mL\u002Fmin\u002F1.73 m\\^2 (obtained =\\\u003C 28 days prior to Step 1 randomization)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT \\[QTc\\] prolongation \\> 500 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome\n* Concomitant use of known potent CYP3A4\u002F5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited\n* Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers\n* Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures\n* Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant 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* Patient must have the ability to understand and the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate\n* Patient must not have had major surgery within 2 weeks prior to Step 1 randomization and patients must have recovered from any effects of any major surgery","ALL","18 Years",{"count":18,"type":19},152,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.",[25,26,27,28,29,30,31],"Pancreatic Acinar Cell Carcinoma","Pancreatic Adenosquamous Carcinoma","Pancreatic Squamous Cell Carcinoma","Resectable Pancreatic Acinar Cell Carcinoma","Resectable Pancreatic Adenocarcinoma","Resectable Pancreatic Adenosquamous Carcinoma","Resectable Pancreatic Carcinoma",[33,34,35,36,37,38,39,40,41,42,43],"Adjuvant","Resected Pancreatic cancer","Pancreatic adenocarcinoma","BRCA1","BRCA2","BRCA1 mutation","BRCA2 mutation","PALB2 PALB2 mutation","PARP inhibitor","PARP","Olaparib","RECRUITING","2026-07-01",{"date":47,"type":48},"2026-07-02","ACTUAL",{"date":50,"type":48},"2021-06-22",{"date":52,"type":19},"2027-10-31",{"name":54,"class":55},"National Cancer Institute (NCI)","NIH",454,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":20,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"100348926","intravital-microscopy-in-human-solid-tumors-100348926","NCT03823144","Intravital Microscopy in Human Solid Tumors","Intravital Microscopy (IVM) in Human Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2\n* Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)\n* Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic\n* Subject must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent\n* Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity to fluorescein\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\n* Renal dysfunction as defined as a glomerular filtration rate (GFR) \\\u003C 45\n* Liver dysfunction as defined by Child-Pugh score \\> 5, or liver function test (LFT)'s 1.5 x above normal range\n* Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein\n* Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigators' opinion deems the patient unsuitable (e.g., abnormal electrocardiography \\[EKG\\], including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test)\n* Any condition that excludes surgical resection as the standard of care for the patient",{"count":65,"type":19},85,[67],"NA","This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.",[70,71,72,73,74,75,76,77,78,79,31,80,81,82,83,84,85,86,87,88,89,90,91],"Solid Tumor, Adult","Clinical Stage IV Gastric Cancer AJCC v8","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Primary Malignant Brain Neoplasm","Metastatic Sarcoma","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Resectable Colorectal Carcinoma","Resectable Liver and Intrahepatic Bile Duct Carcinoma","Resectable Sarcoma","Stage IV Colorectal Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Malignant Brain Neoplasm","Metastatic Breast Carcinoma","Metastatic Liver Carcinoma","Metastatic Pancreatic Carcinoma","Resectable Brain Neoplasm","Resectable Breast Carcinoma","Resectable Gastric Carcinoma","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2026-05-29",{"date":94,"type":48},"2026-06-02",{"date":96,"type":48},"2019-02-28",{"date":98,"type":19},"2027-09-30",{"name":100,"class":101},"Mayo Clinic","OTHER",1]