[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-of-the-pancreas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-of-the-pancreas":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100565919","phase-1-mk2-inhibitor-in-combination-with-mfolfirinox-for-untreated-metastatic-pancreatic-ductal-adenocarcinoma-100565919",false,"NCT06648434","MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma","Phase I Trial of MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma with no prior systemic treatment for advanced or metastatic disease. Patients with mixed cytology in their tumors such as adeno-squamous, mixed neuroendocrine-carcinoma are permitted if the portion of adenocarcinoma is predominant. Prior adjuvant\u002Fneoadjuvant therapy (including FOLFIRINOX or mFOLFIRINOX regimens) is allowed if progression occurred ≥ 12 months from the last dose of that therapy. A biopsy is not required to confirm advanced or metastatic disease.\n* Dose escalation: Diagnosis of advanced inoperable or metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician.\n* Dose expansion: Diagnosis of metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician.\n* Measurable disease by RECIST 1.1.\n* At least 18 years of age\n* ECOG performance status ≤ 1.\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm without transfusion within 2 weeks prior to C1D1\n  * Hemoglobin ≥ 9.0 g\u002FdL without transfusion within 2 weeks prior to C1D1\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN\n  * Creatinine clearance \\> 50 mL\u002Fmin by Cockcroft-Gault\n* Baseline EKG with QTcF ≤ 460 ms.\n* Women of childbearing potential and men who are heterosexually active must agree to use adequate contraception as specified in the protocol. Contraception should continue for 1 month following last dose of zunsemetinib, 6 months following last dose of irinotecan, 9 months following last dose of oxaliplatin, and\u002For 3 months following last dose of fluorouracil. Should a woman (or the female partner of a male participant) become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic pancreatic cancer.\n* History of allogeneic organ or stem cell transplant.\n* Currently receiving any other investigational agents, or receipt of an investigational agent within 2 weeks or 5 half-lives of the agent, whichever is shorter.\n* Receipt of strong and moderate CYP3A4 and CYP2C8 inhibitors (including grapefruit), strong and moderate CYP3A and CYP2C8 inducers (see Appendices H and I), and drugs with QT prolonging potential within 5 half-lives of cycle 1 day 1.\n* Known brain metastases or CNS involvement, because brain metastases are often associated with poor functional status, shortened life expectancy and risk of toxicity.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to zunsemetinib, or other agents used in the study.\n* Clinically significant neuropathy ≥ grade 2.\n* Presence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.\n* Gastrointestinal conditions which could prevent absorption of zunsemetinib, in the opinion of the treating physician.\n* Inability to swallow pills.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia .\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days of C1D1.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.\n* Major surgery within 28 days prior to C1D1. Major surgery refers to any surgical procedure that involves general or regional anesthesia, involves extensive resecting or altering of body parts, carries a higher risk of complications, or requires long recovery times. Central line placement is allowed.\n* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of C1D1.","ALL","18 Years",{"count":19,"type":20},51,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The investigators hypothesize that MK2 inhibition may improve efficacy of mFOLFIRINOX chemotherapy for patients with pancreatic ductal adenocarcinoma (PDAC).",[26,27,28],"Metastatic Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer","Cancer of the Pancreas",[30,31,32],"Pancreatic cancer","Zunsemetinib","FOLFIRINOX","RECRUITING","2026-04-24",{"date":36,"type":37},"2026-04-30","ACTUAL",{"date":39,"type":37},"2025-06-13",{"date":41,"type":20},"2030-05-31",{"name":43,"class":44},"Washington University School of Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100602641","phase-2-stereotactic-body-radiotherapy-plus-fak-and-rafmek-inhibition-in-advanced-pancreatic-adenocarcinoma-100602641","NCT07126158","Stereotactic Body Radiotherapy Plus FAK and RAF\u002FMEK Inhibition in Advanced Pancreatic Adenocarcinoma","Phase II Study of Stereotactic Body Radiotherapy Plus FAK and RAF\u002FMEK Inhibition in Advanced Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is considered borderline resectable or locally advanced per institutional standardized criteria of unresectability or medical inoperability (NCCN guidelines 2.2021 PANC-C 1 of 2).\n* Patients with locoregional adenopathy are eligible as long as all suspicious lymph nodes are deemed to be adjacent to the primary tumor as per radiation oncologist assessment.\n* Patients must have received at least 2 months of systemic chemotherapy, such as FOLFOX, FOLFIRINOX, gemcitabine, nab-paclitaxel, cisplatin, or other regimens, for this disease without progression of local or systemic disease. Newly diagnosed patients may be screened for enrollment in this study and can be enrolled once they have completed 2 months of systemic chemotherapy (and still meet all eligibility criteria) prior to randomization. The last dose of chemotherapy must be ≥ 2 weeks prior to randomization.\n* At least 18 years of age.\n* ECOG performance status ≤ 1.\n* Life expectancy \\> 3 months\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL without transfusion in the preceding 14 days.\n  * Total bilirubin ≤ 1.5 x IULN; no prior history of Gilbert's syndrome\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN or ≤ 5.0 x IULN if due to liver involvement by tumor\n  * Creatinine clearance ≤ 1.5 x IULN or glomerular filtration rate of ≥ 60 mL\u002Fmin\n  * INR ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants\n  * aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants\n  * Albumin ≥ 2.5 mg\u002FdL\n  * Creatine phosphokinase (CPK) ≤ 2.5 x IULN\n* Adequate cardiac function with left ventricular ejection fraction ≥ 55% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n* Corrected QT interval (QTc) \\\u003C 480 ms (as calculated by the Fridericia correction formula).\n* The effects of defactinib and avutometinib on the developing human fetus are unknown. For this reason and because radiation therapy is known to be teratogenic, women of childbearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study and up to 30 days after completion of treatment, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 90 days after completion of the study\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* A history of other malignancy with the exception of prior or concurrent malignancies whose natural history is unlikely to interfere with the safety or efficacy of the investigational regimen (in the opinion of the treating physician).\n* Clinically evident ascites or pleural effusion that requires therapeutic paracentesis or thoracentesis.\n* Prior treatment with a drug of the FAK inhibitor or RAF\u002FMEK inhibitor class, or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Prior anti-human antibody response (AHA or ADA).\n* Currently receiving any other investigational agents or has received any other investigational agents within 4 weeks or 5 half-lives, whichever is shorter, of randomization.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to defactinib, avutometinib, or other agents used in the study, or a history of hypersensitivity to any of the inactive ingredients (hydroxypropylmethylcellulose, mannitol, magnesium stearate) of the investigational product.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy not routinely associated with chemotherapeutic regimen.\n* Requires continued use of warfarin for anticoagulation and cannot stop warfarin or be safely switched to another anticoagulant or direct oral anticoagulant.\n* Has an active autoimmune disease requiring systemic treatment with use of disease modifying agents, corticosteroids, or immunosuppressive drugs within the past 2 years. Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc. is not considered a form of systemic treatment.\n* Received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.\n* Known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected).\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Has a known history of active TB (bacillus tuberculosis).\n* Major surgery within 28 days prior to randomization.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of randomization.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines and aligning with concomitant medication guidance is recommended.\n* Known SARS-Cov2 infection ≤10 days prior to randomization.\n* Exposure to medications (with or without prescriptions), supplements, herbal remedies, or foods with potential for drug-drug interactions with avutometinib and\u002For defactinib within 5 half-lives (if half-life is known) or 14 days prior to randomization. Specifically, this includes:\n\n  * Strong CYP3A4 inhibitors or inducers\n  * Strong CYP2C9 inhibitors or inducers\n  * Strong P-glycoprotein (P-gp) inhibitors or inducers\n  * Strong breast cancer resistance protein (BCRP) inhibitors or inducers.\n* Subjects with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease.\n* Subjects with an active skin disorder that has required systemic therapy within the past year and may confound the interpretation of the safety findings from the study treatments, in the opinion of the investigator.\n* History of medically significant rhabdomyolysis.\n* Patients with concurrent ocular disorders:\n\n  * Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes.\n  * Patients with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n  * Patients with active or chronic, visually significant corneal disorders, other active ocular conditions requiring ongoing therapy or clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy. Examples of visually significant corneal disorders include corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions. Visually significant corneal disorders do NOT include dry eyes, blepharitis, and uncomplicated corneal erosions.\n* Concurrent congestive heart failure, prior history of class III\u002F IV cardiac disease (New York Heart Association \\[NYHA\\]), myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina or severe obstructive pulmonary disease.\n* Any other medical condition (eg, cardiac, gastrointestinal \\[eg, severe heartburn, gastric ulcer, etc\\], pulmonary, psychiatric, neurological, genetic, GI bleeding, substance abuse, alcoholism, etc) within 3 months prior to randomization that, in the opinion of the Investigator, would place the patient at unacceptably high risk for toxicity.\n* Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy, defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment, or still febrile within 48 hours of stopping systemic therapy.\n* Patients are unwilling to adhere to the lifestyle guidance listed in the protocol.",{"count":54,"type":20},36,[56],"PHASE2","Advanced pancreatic cancer patients receiving treatment of adaptive stereotactic body radiotherapy (SBRT) with concurrent and adjuvant defactinib plus avutometinib will have increased progression-free survival (PFS) compared to historical PFS rates for patients receiving adaptive SBRT alone.",[59,28,60,27],"Pancreatic Adenocarcinoma","Pancreas Cancer",[62,63,64,65],"Pancreas cancer","SBRT","FAK","MEK","2026-04-11",{"date":68,"type":37},"2026-04-15",{"date":70,"type":37},"2026-04-10",{"date":72,"type":20},"2030-04-30",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":45},"100514215","microenvironment-tumor-effects-of-radiotherapy---comprehensive-radiobiology-assessment-trial-100514215","NCT05975593","MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial","MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)","METEOR-CRATR","Inclusion Criteria:\n\n* Confirmation of intent to receive radiotherapy for one of the following diagnoses:\n\n  * Cervical cancer\n  * Pancreatic cancer\n* ECOG performance status ≤ 2\n* At least 18 years old\n* Able to understand and willing to sign an IRB-approved written informed consent document\n\nExclusion Criteria:\n\n* Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician",{"count":83,"type":20},60,[85],"NA","This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.",[88,89,90,91,92,93,60,27,94,28],"Locally Advanced Cervical Carcinoma","Locally Advanced Cervical Cancer","Locally Advanced Pancreas Cancer","Locally Advanced Pancreatic Carcinoma","Locally Advanced Pancreatic Cancer","Cervical Cancer","Cancer of the Cervix",[96,97,98,30,99],"Radiotherapy","Chemotherapy","Cervical cancer","Biospecimen","2025-11-07",{"date":102,"type":37},"2025-11-12",{"date":104,"type":37},"2024-01-11",{"date":106,"type":20},"2032-12-31",{"name":43,"class":44}]