[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"InnoPharmax Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100563891","phase-3-d07001-softgel-capsules-and-capecitabine-combination-therapy-in-patients-with-advanced-biliary-tract-cancer-100563891",false,"NCT06622057","D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer","Phase III, Randomized, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens","Inclusion Criteria:\n\n1. Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.\n2. Participant aged at least 18 years at the time of consent.\n3. Participant has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC (cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).\n4. Participant has measurable disease as assessed by central review by RECIST v1.1.\n5. Participant must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether an immune checkpoint inhibitor, such as durvalumab or pembrolizumab, or S-1 (tegafur, gimeracil, and oteracil potassium), was also administered. Oxaliplatin or carboplatin may be substituted for cisplatin when renal or auditory function is of concern. Participants also have failed (disease progression or intolerance) on, or refused FOLFOX chemotherapy, including modified FOLFOX variants, or failed on irinotecan + fluorouracil-based chemotherapy.\n6. Participants with tumors expressing the following biomarkers may be enrolled even if they have not previously received FOLFOX but have received appropriate targeted therapies until disease progression or intolerance: fibroblast growth factor receptors (FGFR) aberrations, microsatellite instability biomarker\u002Fdeficient DNA mismatch repair, Tumor Mutation Burden-high, or mutations in isocitrate dehydrogenase, BRAF, HER2, NTRK, RET, or KRAS G12C.\n7. Participant has ECOG PS of 0-2.\n8. Participant's life expectancy is ≥12 weeks.\n9. Participant has adequate bone marrow function, demonstrated by:\n\n   1. Absolute neutrophil count ≥1500 cell\u002Fmm3.\n   2. Platelet count ≥85,000 cells\u002Fmm3.\n   3. Hemoglobin ≥9 g\u002FdL.\n10. Participant has adequate liver function, demonstrated by:\n\n    1. Aspartate transaminase and alanine transaminase ≤2.5 × upper limit of normal (ULN), or ≤5.0 × ULN in the case of liver lesions.\n    2. Total bilirubin ≤1.5 × ULN.\n    3. Albumin ≥3.0 g\u002FdL.\n    4. International normalized ratio \\\u003C1.5.\n11. Participant has adequate renal function, demonstrated by creatinine clearance ≥ 45 mL\u002Fmin calculated by Cockcroft-Gault formula or estimated glomerular filtration rate ≥ 45 mL\u002Fmin\u002F1.73 m2 by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine equation.\n12. No clinically significant abnormalities in coagulation results.\n13. Participant is eligible to participate if not pregnant (as demonstrated by serum pregnancy testing at Screening), not breastfeeding, and at least 1 of the following conditions applies:\n\n    1. Not of childbearing potential (CBP). Participants of non-childbearing potential are defined as those with functioning ovaries with a documented history of tubal ligation or hysterectomy or who are postmenopausal, as defined by 12 months of spontaneous amenorrhea with an appropriate clinical profile, e.g., age appropriate, \\>45 years, in the absence of hormone replacement therapy. If necessary, a blood sample for follicle stimulating hormone will be obtained to confirm postmenopausal status.\n    2. A participant of CBP who is sexually active with a partner who could impregnate them agrees to use a highly effective form of contraception during the study and for at least 6 months after the EOS intervention.\n14. Participants with partners of childbearing potential whom they could impregnate must agree to use contraception during the study and for 3 months after the EOS intervention.\n15. Participants who are able to donate sperm must refrain from sperm donation during the study and for 3 months after the EOS intervention.\n16. Participant is willing to comply with the protocol-required visit schedule and visit requirements.\n17. More than 14 days have elapsed between the participant completing a prior line of chemotherapy or targeted therapy, and enrollment. More than 28 days have elapsed between the participant receiving concurrent radiotherapy (CCRT) and enrollment\n\nExclusion Criteria:\n\n1. Participant has a diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent.\n2. Participant discontinued prior gemcitabine due to pulmonary or hepatic toxicity or hemolytic uremic syndrome, hypersensitivity, allergic reaction, or intolerance.\n3. Participant had a prior unanticipated severe reaction to capecitabine or metabolites or to fluoropyrimidine therapy.\n4. Participant received treatment with brivudine, sorivudine, or its chemically related analogs ≤28 days prior to the date of enrollment.\n5. Participant is currently receiving flucytosine treatment.\n6. Participant has residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted).\n7. Participant has any gastrointestinal disorder or prior gastrointestinal surgery that would significantly impede absorption of an oral agent, such as gastrectomy, Crohn's disease, ulcerative colitis, or short gut syndrome.\n8. Participant has known brain or leptomeningeal metastases.\n9. Participant had major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days.\n10. Participant has any active disease or condition that would not permit compliance with the protocol.\n11. Participant has clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, New York Heart Association Grade 2 or greater), or uncontrolled serious cardiac arrhythmia.\n12. Participant has documented cerebrovascular disease.\n13. Participant has a seizure disorder not controlled with medication (based on Investigator's decision).\n14. Participant has received an investigational agent within 28 days of enrollment.\n15. Participant has an uncontrolled active viral, bacterial, or systemic fungal infection.\n16. Participants with positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus antibody (anti-HCV) and detectable hepatitis B virus (HBV) DNA ≥2000 copies\u002FmL or hepatitis C virus (HCV) RNA above the institutional lower limit of quantification are excluded. Participants with resolved HBV infection (negative HBsAg and positive hepatitis B core antibody \\[anti-HBc\\]) are eligible if HBV DNA is \\\u003C2000 copies\u002FmL. Participants with positive anti-HCV antibody must have completed curative antiviral therapy and have undetectable HCV RNA by PCR to be eligible.\n17. Has positive human immunodeficiency virus antibody.\n18. Participant has received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks before Screening.\n19. Participant has a history of drug or alcohol abuse within the year before signing the informed consent form.\n20. Participant has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in or compliance with the clinical trial.","ALL","18 Years",{"count":19,"type":20},195,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).\n\nEligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.",[26],"Biliary Tract Cancer (BTC)",[28,29,30,31],"BTC","cholangiocarcinoma","Biliary Tract Cancer","third-line","RECRUITING","2026-06-09",{"date":35,"type":36},"2026-06-11","ACTUAL",{"date":33,"type":36},{"date":39,"type":20},"2027-12-31",{"name":41,"class":42},"InnoPharmax Inc.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100444325","phase-2-study-of-combination-therapy-of-d07001-softgel-capsules-and-xelodats-1-in-subjects-with-advanced-biliary-tract-cancer-100444325","NCT05065957","Study of Combination Therapy of D07001-Softgel Capsules and Xeloda\u002FTS-1 in Subjects With Advanced Biliary Tract Cancer","Open-Label, Multicenter, Phase II\u002FIII Study of Combination Therapy of D07001-Softgel Capsules and Xeloda\u002FTS-1 in Subjects With Advanced Biliary Tract Cancer After Gemcitabine and Cisplatin-Based Treatment Failure","Inclusion Criteria:\n\n1. Male or female patients aged 18 years or older at screening (aged 20 years or older in Taiwan)\n2. Histopathological or cytologic diagnosis of unresectable metastatic or locally advanced BTC (cholangiocarcinoma, gallbladder cancer or ampullary carcinoma)\n3. Subject must have failed from first line gemcitabine and cisplatin-based chemotherapy\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1\n5. Life expectancy is \\>12 weeks\n6. Adequate bone marrow function, demonstrated by:\n\n   1. Absolute neutrophil count (ANC) ≥1,500 cell\u002Fmm3\n   2. Platelet count ≥ 100,000 cells\u002Fmm3\n   3. Hemoglobin ≥ 9 g\u002FdL\n7. Adequate liver function, demonstrated by:\n\n   1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases\n   2. Total bilirubin ≤1.5 x ULN\n   3. Albumin ≥3.0 g\u002FdL\n   4. International normalized ratio (INR) \\\u003C1.5\n8. Adequate renal function, demonstrated by:\n\n   1. Serum creatinine ≤1.5 x ULN\n   2. Creatinine clearance ≥ 50mL\u002Fmin calculated by Cockcroft-Gault formula or eGFR ≥ 50mL\u002Fmin\u002F1.73m2 by 2021 CKD-EPI Creatinine Equation\n9. A negative serum pregnancy test at screening and is not breastfeeding in woman of childbearing potential\n10. Women of childbearing potential or male subjects must use a medically acceptable form of contraception as 2 barrier methods (e.g., combination of condom, diaphragm, or intrauterine device), hormonal contraception (estrogen or progesterone agents) or 1 barrier method in combination with spermicide. Birth control is required 1 month prior to screening, for the duration of their study participation, and for 1 month after the end of the study; female partners of male subjects must adhere to the same birth control methods.\n11. Provision of a signed and dated written Informed Consent Form (ICF) prior to any study specific procedures\n12. Subject is willing to comply with protocol-required visit schedule and visit requirements\n13. No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment\n14. Subject has not received other chemotherapy since first-line treatment\n\nExclusion Criteria:\n\n1. Have prior chemotherapy regimen other than first line gemcitabine and cisplatin-based therapy for unresectable metastatic or locally advanced BTC Note: prior fluoropyrimidine base (including capecitabine, carmofur (HCFU), doxifluridine, fluorouracil (5-FU), and tegafur) chemotherapy (including fluoropyrimidine monotherapy or combination therapy) are allowed as postsurgical adjuvant therapy.\n2. Diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent\n3. Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or hemolytic uremic syndrome (HUS) or hypersensitivity, allergic reaction, or intolerance\n4. Known or suspected hypersensitivity to capecitabine, tegafur, gimeracil, oteracil potassium, oxaliplatin or other platinum compounds, leucovorin products, folic acid or folinic acid, 5-fluorouracil or their excipients.\n5. Prior discontinuation of fluoropyrimidine because of any unexpected or severe reaction.\n6. Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of enrollment.\n7. Under flucytosine treatment.\n8. Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted)\n9. Any GI disorder which would significantly impede absorption of an oral agent\n10. Known brain or leptomeningeal metastases\n11. Major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days\n12. Any active disease or condition that would not permit compliance with the protocol\n13. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association \\[NYHA\\] Grade 2 or greater), or uncontrolled serious cardiac arrhythmia\n14. Have documented cerebrovascular disease. Subjects with the disease may be excluded, but if the investigator assesses that they are asymptomatic or well controlled could be enrolled.\n15. Have a seizure disorder not controlled on medication (based on decision of Investigator)\n16. Received an investigational agent within 28 days of enrollment\n17. Have an uncontrolled active viral, bacterial, or systemic fungal infection\n18. Known human immunodeficiency virus (HIV) infection\n19. Have HBsAg (hepatitis B surface antigen) positive with HBV-DNA ≥2000 copies\u002Fml and\u002For anti-HCV antibody (HCV) positive with HCV-RNA positive.\n20. Received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks prior to screening\n21. History of drug or alcohol abuse within last year\n22. Have any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in, and compliance with, a clinical trial",{"count":51,"type":20},180,[53,23],"PHASE2","The primary objective are:\n\nTo assess the safety and tolerability of the combination of D07001-softgel capsules and Xeloda\u002FTS-1.\n\nTo evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda\u002FTS-1, as assessed by disease control rate (DCR).",[30],"2025-04-28",{"date":58,"type":36},"2025-04-30",{"date":60,"type":36},"2022-03-29",{"date":62,"type":20},"2026-12",{"name":41,"class":42},5,""]