[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Delta-Fly Pharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100545458","phase-1-dfp-10917-in-combination-with-venetoclax-in-relapsed-or-refractory-acute-myeloid-leukemia-100545458",false,"NCT06382168","DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia","Phase I\u002FII Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Signed informed consent and ability to comply with protocol requirements.\n* Histologically or pathologically confirmed diagnosis of acute myeloid leukemia based on World Health Organization classification that has relapsed after, or is refractory to, up to 2 prior induction regimens that may have included intensive chemotherapy (e.g., \"7+3\" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine with\u002Fwithout venetoclax), or targeted therapy (e.g., FLT-3, IDH 1\u002F2, BCL-2, monoclonal antibody).\n\n(Relapse is defined as reemergence of ≥5% leukemia blasts in bone marrow or ≥1% blasts in peripheral blood 90 days to 24 months after first complete remission or complete remission with incomplete hematologic recovery. Refractory acute myeloid leukemia is defined as persistent disease ≥28 days after initiation of intensive induction therapy (up to 2 induction cycles) or relapse \\\u003C90 days after first complete remission or complete remission with incomplete hematologic recover. Refractory disease for patients undergoing hypomethylating agent induction is defined as lack of remission following at least 2 cycles of epigenetic therapy without reduction in bone marrow blast status).\n\n* Adequate organ function as defined by the following laboratory values:\n\n  * Creatinine clearance \\>30 mL\u002Fmin (by Cockcroft-Gault method),\n  * Total serum bilirubin \\\u003C1.5 × upper limit of normal unless due to Gilbert's syndrome, leukemic organ involvement, hemolysis or considered an effect of regular blood transfusions,\n  * Alanine aminotransferase and aspartate aminotransferase \\\u003C3 × upper limit of normal, unless due to leukemic organ involvement.\n* Eastern Cooperative Oncology Group performance status of 0, 1, or 2).\n* Projected life expectancy of ≥12 weeks.\n* Female patients of childbearing potential must:\n\n  * Have a negative serum or urine pregnancy test prior to study treatment initiation.\n  * Agree to use at least 1 highly effective form of contraception during study treatment and for 3 months after the last dose.\n* Male patients with female partners of childbearing potential must -- Agree to use at least 1 highly effective form of contraception during study treatment and for at least 3 months after the last dose.\n\nExclusion Criteria:\n\n* Any \\>Grade 1 persistent clinically significant toxicities from prior chemotherapy.\n* Leukemic blast count \\>25 × 109\u002FL. Hydroxyurea permitted to control leukocytosis.\n* Known history of human immunodeficiency virus or active hepatitis B or active hepatitis C infection.\n* Concomitant malignancies for which patients are receiving active therapy at the time of signing consent. Patients with adequately treated basal or squamous cell carcinoma of the skin, adequately treated carcinoma in situ (e.g., cervix), breast cancer receiving adjuvant endocrine therapy or prostate cancer not under active systemic treatment other than hormonal therapy may enroll irrespective of the time of diagnosis, with Medical Monitor approval.\n* Known active central nervous system involvement by leukemia. Patients with previously diagnosed central nervous system leukemia are eligible if the central nervous system leukemia is under control and intrathecal treatment may continue throughout the study.\n* Diagnosis of acute promyelocytic leukemia.\n* Prior exposure to anticancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents within 14 days of the first day of study treatment or within 5 half-lives prior to first dose of study treatment. Note that hydroxyurea up to 5 g daily × 3 days is permitted to reduce elevated white blood cell (WBC) count.\n* Venetoclax exposure in more than 1 prior regimen.\n* Prior exposure to biologic agents (e.g., monoclonal antibodies) for anti-neoplastic intent within 14 days prior to first dose of study drug.\n* Prior hematopoietic stem cell transplantation.\n* Malabsorption syndrome or other condition that precludes enteral route of administration.\n* Pregnancy or lactation.\n* Active uncontrolled systemic infection (viral, bacterial, or fungal).\n* Ongoing treatment with strong or moderate CYP3A inhibitors or CYP3A inducers, P-gp inhibitors, or narrow therapeutic index P-gp substrates that cannot be discontinued at least 1 week prior to start of venetoclax dosing excluding antifungal prophylaxis.","ALL","18 Years",{"count":19,"type":20},39,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This Phase I\u002FII trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg\u002Fm²\u002Fday of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants.",[27],"Leukemia, Myeloid, Acute","RECRUITING","2025-08-31",{"date":31,"type":32},"2025-09-03","ACTUAL",{"date":34,"type":32},"2024-06-12",{"date":36,"type":20},"2026-06-30",{"name":38,"class":39},"Delta-Fly Pharma, Inc.","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":5},"100358126","phase-1-trial-of-dfp-14927-in-advanced-solid-tumors-100358126","NCT03943004","Trial of DFP-14927 in Advanced Solid Tumors","A Phase I Study of DFP-14927 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients must have histologically (or cytologically) confirmed diagnosis of solid tumor, refractory after standard therapy for the disease or for which conventional systemic therapy is not reliably effective or no effective therapy is available. Note: For expansion cohorts patients must have histologically (or cytologically) confirmed diagnosis of gastroesophageal cancer, pancreatic cancer, or cholangiocarcinoma that has relapsed or is refractory to standard therapy.\n2. Aged ≥ 18 years.\n3. ECOG Performance Status of 0 or 1.\n4. Adequate clinical laboratory values defined as:\n\n   1. absolute neutrophil count ≥ 1.5 x 10⁹\u002FL\n   2. platelets ≥ 100 x 10⁹\u002FL\n   3. hemoglobin ≥ 9.0 g\u002FdL (transfusions permissible)\n   4. plasma creatinine ≤ 1.5 x upper limit of normal (ULN) for the institution or calculated clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula)\n   5. total bilirubin ≤ 1.5 x ULN\n   6. alanine transaminase (ALT) and aspartate transaminase (AST) \\\u003C 2.5 x ULN (\\\u003C5 x ULN if documented hepatic metastases)\n   7. prothrombin time (PT) ≤1.2 x ULN, partial thromboplastin time (PTT) ≤ 1.2 ULN, and international normalized ratio (INR) ≤ 1.5\n5. Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, uncontrolled diabetes mellitus, or other organ dysfunctions.\n6. Patients may have measurable or non-measurable disease as defined by RECIST 1.1.\n7. Signed Informed-consent prior to the start of any study specific procedures.\n8. Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.\n\nExclusion Criteria:\n\n1. Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for targeted therapies prior to this study entry.\n2. Have not recovered from adverse events (must be Grade ≤1) due to agents administered more than 4 weeks earlier.\n3. Have had any major bleeding episodes (variceal bleeds, hemorrhagic strokes, internal abdominal bleeds, etc.) within 6 months prior to starting study drug.\n4. Known hypersensitivity to any study drug component (such as pegylated medications).\n5. Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow\u002Fstem cell transplantation.\n6. Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.\n7. Pregnant or lactating individuals.\n8. Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.\n9. Known history of HIV, HBV or HCV infection.\n10. Documented or known bleeding disorder.\n11. Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low dose DVT or line prophylaxis is allowed).\n12. Clinically evident CNS metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment. Patients with primary CNS malignancies are excluded.\n13. Patients with a significant cardiovascular disease or condition, including:\n\n    1. Myocardial infarction within 6 months of study entry\n    2. NYHA Class III or IV heart failure\n    3. Uncontrolled dysrhythmias or poorly controlled angina.\n    4. History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row) and\u002For risk factors (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n    5. Baseline prolongation of QT\u002FQTc interval (repeated demonstration of QTc ≥ 450 msec for men and 470 msec for women). QTc values up to 500 msec will be acceptable where patient's medical history, e.g. bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled",{"count":49,"type":20},30,[23],"This is a Phase I, open-label, single-arm, dose escalation study of DFP-14927 intravenous infusion administered to patients with refractory or relapsed solid tumors.",[53,54],"Solid Tumor","Cancer",[56,57],"advanced solid tumors","refractory or relapsed tumors","2025-02-27",{"date":60,"type":32},"2025-03-03",{"date":62,"type":32},"2019-09-30",{"date":64,"type":20},"2026-06-01",{"name":38,"class":39},""]