TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05332210
Drug: HBM9161 Injection (680mg)
Approvals — FDA: no, EMA: no, PMDA: no
Description: HBM9161 Injection
Study: NCT06572813
Drug: mFOLFIRINOX
Approvals — FDA: no, EMA: no, PMDA: no
Description: Combination of oxaliplatin, fluorouracil, irinotecan, leucovorin calcium
Study: NCT04889183
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive a matching placebo sc. once weekly during the treatment period of 24 weeks.
Study: NCT05602142
Drug: [11C]CPPC PET ligand
Approvals — FDA: no, EMA: no, PMDA: no
Description: Radioactive PET ligand to determine microglia expression of colony stimulating factor 1 receptor (CSF1R).
Study: NCT06219317
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: standard saline solution
Study: NCT03459729
Drug: Antitumor B
Approvals — FDA: no, EMA: no, PMDA: no
Description: Study participants will take the natural botanical compound ATB during a short window (seven to 28 days). It will be administered at a dose of 1200 mg three times per day (roughly spaced every 8 hours).
Study: NCT06133972
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo s.c. monthly
Study: NCT06223074
Drug: Nasal Methylprednisolone (MT)
Normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Group 2 will receive the dose intranasal equivalent to 1g of methylprednisolone for 3 or 5 days according to the severity of the relapse
Study: NCT05132504
Drug: Folfirinox
Approvals — FDA: no, EMA: no, PMDA: no
Description: Once eligibility has been confirmed and the patient has been registered to the study, the patient will begin induction modified FOLFIRINOX (Oxaliplatin, Leucovorin, Irinotecan, 5-Fluorouracil) chemotherapy treatment. Each cycle is 14 days; a total of six cycles will be administered. Patients will receive growth factor support at the discretion of treating physician.
Study: NCT05844137
Drug: T2D medication management
Approvals — FDA: no, EMA: no, PMDA: no
Description: T2D medication management
Study: NCT04231760
Drug: Inhaled Nitric Oxide
Normalized name: nitric oxide Inhalant Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inhaled nitric oxide, which consists of breathing medical grade air (21% O2) with 40 parts per million of nitric oxide.
Study: NCT04231760
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inhaled placebo, which consists of breathing medical grade air (21% O2).
Study: NCT05526391
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: TAK-341 placebo-matching IV infusion
Study: NCT06611319
Drug: Prevention of Venous Thromboembolism
Approvals — FDA: no, EMA: no, PMDA: no
Description: Direct oral anticoagulant
Study: NCT06611319
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT05035407
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 30 mg/kg IV infusion over 1 hour (+ 10 min) Once daily x 2 doses (Days -6 and -5)
Study: NCT06745297
Drug: Placebo matching BI 3776528
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matching BI 3776528
Study: NCT05511246
Drug: Venous ethanol
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol
Study: NCT05928728
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo once daily
Study: NCT05806086
Drug: Panfoshu+Conventional Treatment（program-A）
Approvals — FDA: no, EMA: no, PMDA: no
Description: On the basis of conventional treatment, panfoshu combined therapy was added.Panfoshu was taken orally once a day on an empty stomach, one capsule at a time. 1 course of treatment was 6mon, which was taken 10 days a month, stopped for 20 days for 3 months, and observed for another 3 months(unmedicated). Usage and dosage: adults and adolescents above 12yrs take one capsule (7.0mg) every day, children (1yrs-12yrs) take one capsule (3.5mg) every day.
Study: NCT05806086
Drug: Panfoshu+Conventional Treatment（program-B）
Approvals — FDA: no, EMA: no, PMDA: no
Description: On the basis of conventional treatment, panfoshu combined therapy was added.Panfoshu was taken for 30 days in the first month, stopped in the second month, taken for 10 days and stopped for 20 days in a row for 3 months, and finally observed for 1 month. Usage and dosage: adults and adolescents above 12yrs take one capsule (7.0mg) every day, children (1yrs-12yrs) take one capsule (3.5mg) every day.
Study: NCT06525597
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT05693766
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 2000 mg taken by mouth twice daily for 7 days on, 7 days off
Study: NCT06012760
Drug: Standard Medical Care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
Study: NCT04954456
Drug: QLS31901
Approvals — FDA: no, EMA: no, PMDA: no
Description: QLS31901 is a bispecific antibody specifically targeting PD-L1 and TGF-β.In part 1,the QLS31901 will be administered in sequential cohorts on day 1 of every 21-day cycle (3 weeks) via IV infusion.In part 2,the QLS31901 will be administered in parallel cohorts(selected dose and dosing frequency ) on day 1 of every 2week or every 3week via IV infusion
Study: NCT05643638
Drug: Corticosteroids
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: All enrolled subjects in this trial must receive corticosteroids at a minimum dose of oral prednisone 2 mg/kg/day (or methylprednisolone 1.6 mg/kg/day IV) as therapy for aGvHD for at least for 72 hours post enrollment.
Study: NCT06483373
Drug: SPH7854
Approvals — FDA: no, EMA: no, PMDA: no
Description: SPH7854： Orally, 50-3200mg
Study: NCT06483373
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo：Orally；
Study: NCT06534437
Drug: MEN1703
Approvals — FDA: no, EMA: no, PMDA: no
Description: MEN1703 is a potent dual inhibitor of proviral integration site for Moloney murine leukemia virus (PIM) kinases and Fms-like tyrosine kinase 3 (FLT3).
Study: NCT05490680
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Oral Film
Study: NCT05905328
Drug: CTO1681 10 μg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered 3 times daily for 15 days (initial cohort).
Study: NCT05905328
Drug: CTO1681 20 μg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered 3 times daily for 15 days (successive cohort).
Study: NCT05905328
Drug: CTO1681 30 μg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered 3 times daily for 15 days (successive cohort).
Study: NCT06484556
Drug: NW-301V
Normalized name: DRESSING,HYDRASORB 4IN X 4IN KEN#1694-NW
Approvals — FDA: no, EMA: no, PMDA: no
Description: TCR-T T cell targeting KRAS G12V mutation
Study: NCT06484556
Drug: NW-301D
Normalized name: DRESSING,HYDRASORB 4IN X 4IN KEN#1694-NW
Approvals — FDA: no, EMA: no, PMDA: no
Description: TCR-T T cell targeting KRAS G12D mutation
Study: NCT05492201
Drug: LY3873862
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally.
Study: NCT05492201
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally.
Study: NCT06470048
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol
Study: NCT05322408
Drug: HCW9218
Approvals — FDA: no, EMA: no, PMDA: no
Description: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
Study: NCT04902131
Drug: A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose cross-over bioequivalence trial
Study: NCT04902131
Drug: A MENOPUR powder including solvent for solution for injection, 75 IU
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose cross-over bioequivalence trial
Study: NCT06005428
Drug: CRD-4730
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral CRD-4730 in capsule form
Study: NCT06005428
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to match CRD-4730 in capsule form
Study: NCT06123286
Drug: Omega 3 FA (Fish Oil)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 capsules of Omega 3 FA (Fish Oil) (Nordic Naturals Ultimate Omega) \[650 mg EPA and 450 mg DHA per capsule\] daily for 12 weeks
Study: NCT06153420
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo for CIN-103 BID
Study: NCT06213506
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 dose of Placebo administered intramuscularly at Day 57 to adults in the Adults_Control group.
Study: NCT06456346
Drug: Hydroxyurea placebo
Normalized name: Hydroxyurea
DrugBank: Hydroxyurea (DB01005)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral capsule placebo
Study: NCT05798520
Drug: BIIB091
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered as specified in the treatment arm.
Study: NCT05798520
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered as specified in the treatment arm.
Study: NCT05465031
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matching the sacubitril/valsartan (Entresto®) administered in the target dose matching the dosing of 200 mg b.i.d. (97/103 mg) for the period of 24 months. In case of intolerance of target dose of placebo, the physician-in-charge will be able to reduce the dose to placebo matching the dose of 100 mg b.i.d. (49/51mg). Physicians will be strongly encouraged to evaluate the possibility of drug dose uptitration to the target dose of placebo matching the dose of 200 mg b.i.d.
Study: NCT06200467
Drug: Placebo to BI 456906
Approvals — FDA: no, EMA: no, PMDA: no
Description: Solution for injection
Study: NCT06640413
Drug: [177Lu]Lu-OncoFAP-23
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3.7, 7.4, or 11.1 GBq to define the RD
Study: NCT05686070
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to asundexian, once daily, oral
Study: NCT04947527
Drug: Test varnish
Normalized name: mumps skin test antigen
Approvals — FDA: no, EMA: no, PMDA: no
Description: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
Study: NCT06405139
Drug: Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nanoliposomal irinotecan 60mg/m2; Oxaliplatin 85 mg/m2; Capecitabine 800 mg/m2 twice daily, day 1 to 7; repeated every two weeks.
Study: NCT05211986
Drug: IMM01-STEM
Normalized name: AKEBIA STEM
Approvals — FDA: no, EMA: no, PMDA: no
Description: IMM01-STEM is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules.
Study: NCT05733390
Drug: JZP541
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral suspension
Study: NCT05653713
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV dose of 0.9% saline
Study: NCT04947527
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
Study: NCT06639087
Drug: AZD5462
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive AZD5462 on top of dapagliflozin once daily.
Study: NCT05885542
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Double-blind placebo oral solution administered once
Study: NCT05913037
Drug: Test group (Group A): FCN-159 8 mg, orally, once daily;
Approvals — FDA: no, EMA: no, PMDA: no
Description: After completing all screening visit items, qualified patients will be randomly assigned to the test group (Group A) or control group (Group B) in a 2:1 ratio, and receive FCN-159 or placebo within 3 days after randomization.
Study: NCT06177678
Drug: TFC-003
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.
Study: NCT04881240
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.
Study: NCT06177678
Drug: COSOPT ophthalmic solution
Normalized name: Cosopt Ophthalmic Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.
Study: NCT04921033
Drug: Standart of care
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Budesonide 9mg/day for mild disease~* Prednisolone 1mg/kg, maximum 40mg/day in decreasing doses (40mg for 4 weeks followed by a fixed taper for 6 weeks) for moderate-to-severe disease for 12 weeks.~* Patients with moderate to severe disease in the steroid group will also receive 2mg/kg azathioprine. The dose of azathioprine will be adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase \[ALT\], aspartate transaminase \[AST\], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine.
Study: NCT05089227
Drug: treatment intervention
Normalized name: Hongo Killer Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: for a total of 12 weeks, prophylactic heparin therapy during hospitalization followed by prophylactic oral anticoagulation with apixaban
Study: NCT05089227
Drug: treatment standard
Approvals — FDA: no, EMA: no, PMDA: no
Description: during hospitalization prophylactic heparin therapy followed by management without prophylactic anticoagulation.
Study: NCT06444763
Drug: Maolactin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Once daily dose of 2 capsules containing a total of 500mg/day Maolactin
Study: NCT06181435
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form:~Injection solution Route of administration: SC injection
Study: NCT04814771
Drug: [14C] TS-142
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq \[14C\]TS-142 as an oral solution
Study: NCT05868876
Drug: AK127 Q3W IV infusion ,AK104 10mg/kg Q3W IV infusion
Approvals — FDA: no, EMA: no, PMDA: no
Description: AK127 is administered intravenously according to the frequency Q3W and different dosage of administration at different stages.AK104 is administered intravenously according to the frequency and dosage 10mg/kg Q3W.
Study: NCT04675983
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered orally
Study: NCT06429137
Drug: Matching placebo to BI 3731579
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo to BI 3731579
Study: NCT06171178
Drug: ASP1012
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous (IV) infusion
Study: NCT05089084
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: sterile normal saline (0.9% NaCl)
Study: NCT06083753
Drug: PIPE-307 Dose B
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive daily oral doses of PIPE-307
Study: NCT06083753
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive daily oral matching dose of Placebo
Study: NCT05407792
Drug: Staphylococcus and Neisseria Tablets
Normalized name: Staphylococcus simulans
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.3 mg/ tablet, 4 tablets each time, 3 times a day (Shandong Qilu Pharmaceutical Co., LTD.), the course of treatment was more than 3 months.
Study: NCT06485232
Drug: Universal BCMA CAR-T; Universal CD19 CAR-T
Approvals — FDA: no, EMA: no, PMDA: no
Description: Universal BCMA CAR-T; Universal CD19 CAR-T
Study: NCT04689828
Drug: ARDT
Normalized name: CHLAMYDOMONAS REINHARDTII
Approvals — FDA: no, EMA: no, PMDA: no
Description: administered orally on a continuous basis, as per package insert and guidelines
Study: NCT05070728
Drug: FAI Insert
Approvals — FDA: no, EMA: no, PMDA: no
Description: Yutiq 0.05 mg contains 0.05 mg FA and was designed to deliver FA into the vitreous humor for at least 24 weeks.~Yutiq 0.05 mg was administered to the study eye by injection through the pars plana using a pre-loaded applicator with a 25-gauge needle.
Study: NCT06178146
Drug: Immunosuppressant
Normalized name: Immunosuppressant
Approvals — FDA: no, EMA: no, PMDA: no
Description: Grade 2 irAEs: corticosteroid alone Grade 3 and above irAEs: corticosteroids combined with other immunosuppressants Steroid-refractory irAE: After 48-72 hours of systemic steroid therapy, the symptoms do not improve or worsen, and the second-line immunosuppressant therapy is adopted.
Study: NCT06354257
Drug: EE/LNG
Approvals — FDA: no, EMA: no, PMDA: no
Description: One dose of EE and LNG is administered on Day 1 of treatment period 1 and one dose of EE/LNG co-administered with GSK3036656 DL 2 is given on Day 15 of treatment period 3.
Study: NCT06033950
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching oral placebo.
Study: NCT06518603
Drug: Caffeine citrate 20mg/kg/day
Approvals — FDA: no, EMA: no, PMDA: no
Description: Caffeine citrate 20mg/kg/day given orally once daily for 28 days
Study: NCT06244303
Drug: manual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)
Normalized name: Colgate Total Mouthwash
Approvals — FDA: no, EMA: no, PMDA: no
Description: Toothpaste, toothbrush \& mouthwash regime
Study: NCT06244303
Drug: manual toothbrush + Colgate dental cream
Normalized name: Colgate Dental Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: toothpaste + toothbrush
Study: NCT06652529
Drug: AROG4-01
Approvals — FDA: no, EMA: no, PMDA: no
Description: AROG4-01 will be administered as IV infusions in biweekly dosing interval. The first dosing day will be Day 1, 28 days cycle.
Study: NCT06652529
Drug: AROG4-01
Approvals — FDA: no, EMA: no, PMDA: no
Description: AROG4-01 will be administered as IV infusions in biweekly dosing interval. The first dosing day will be Day 1, 28 days cycle.~This study is an open label, Phase 1 dose escalation trial with two expansion cohorts. The study consists of two parts:~* Part A: Dose escalation in patients with advanced solid tumors. Approximately 8 to 20 patients in total will be enrolled in part A, covering up to 6 dose levels.~* Part B: At the dose expansion phase, AROG4-01 two cohorts of ten patients with advanced solid tumor each will be recruited. One cohort of patients with advanced MPM (cohort 1) and a second cohort of patients with other solid tumors (cohort 2).
Study: NCT04909801
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Study: NCT06158490
Drug: JYP0061 15 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants in the JYP0061 15 mg group will receive a 15 mg oral tablet of JYP0061 once daily for 12 weeks.
Study: NCT06158490
Drug: JYP0061 30 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: articipants in the JYP0061 30 mg group will receive a 30 mg oral tablet of JYP0061 once daily for 12 weeks.
Study: NCT06158490
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants in the placebo group will receive a matching placebo tablet once daily for 12 weeks.
Study: NCT06662942
Drug: StrataMGT
Approvals — FDA: no, EMA: no, PMDA: no
Description: StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.
Study: NCT06662942
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.
Study: NCT06680531
Drug: YZJ-1139 tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: YZJ-1139 tablets are administered orally single dose
Study: NCT04872543
Drug: ASTX727
Approvals — FDA: no, EMA: no, PMDA: no
Description: ASTX727 will be self-administered orally by the patient on a once daily basis, days 1 through 5 of each 21-day cycle. Cycle 1 day 1 (C1D1) is defined as the first day that ASTX727 is administered.
Study: NCT04768426
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles.
Study: NCT05327114
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered intravenously.
Study: NCT05489211
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administered orally
Study: NCT05489211
Drug: Leucovorin LV
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered as an IV
Study: NCT06465823
Drug: Bumetanide
Normalized name: Bumetanide
DrugBank: Bumetanide (DB00887)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients in the Bumetanide group will be treated for 3 months with a dose of 0.02 mg/kg twice a day, oral administration. It will be labeled (pre-printed and indistinguishable) with the randomization number and site number and will be delivered in separate blocks during the first, second and fourth appointment.~The patients will start the treatment with half of the full target dose during the first week:~* If the target dose is 0.5mg BID, only the morning dose will be administrated.~* If the target dose is 1.0 mg BID the dose will be 0.5 mg BID.~* If the target dose is 1.5mg BID, the morning dose will be 1.0 mg, the evening dose will be 0.5 mg.~* If the target dose is 2.0 mg BID the dose will be 1.0 mg BID The patient will continue with the full dose starting from Visit 2 after 1 week of dosing.
Study: NCT06465823
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in the control (placebo) group will be given placebo for 3 months twice a day, oral administration. The Placebo tablets will be visually indistinguishable from Bumetanide and packaged as Bumetanide. The placebo will be labeled (pre-printed and indistinguishable) with the randomisation number and site number and will be delivered in separate blocks during the first, second and fourth visits.
Study: NCT05574114
Drug: Conditioning chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Day -5 to -3: Patients will receive standard of care lymphodepleting chemotherapy