AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT05330364
Drug: Chidamide
RxNorm normalized name: Chidamide
DrugBank: Tucidinostat (DB06334)
FDA approved: no
EMA approved: no
PMDA approved: yes
Description: Chidamide 30mg/d p.o. begin at day 1, twice per week, during a 28-days cycle.
Trial: NCT05330364
Drug: Cladribine
RxNorm normalized name: Cladribine
DrugBank: Cladribine (DB00242)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cladribine 5mg/m2/d i.v. d1-5, once per day, during a 28-days cycle.
Trial: NCT05418582
Drug: DZD9008 and intraconazole
RxNorm normalized name: cytarabine and daunorubicin
DrugBank: Daunorubicin (DB00694)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: All subjects will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with itraconazole after the wash-out period.
Trial: NCT05418582
Drug: DZD9008 and carbamazepine
RxNorm normalized name: Carbamazepine
DrugBank: Carbamazepine (DB00564)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: All subjects will receive DZD9008 single dose on Day 1, and the second dose of DZD9008 along with carbamazepine after the wash-out period.
Trial: NCT00870636
Drug: Bevacizumab (Avastin)
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Dosage of 0.75mg/0.03ml intravitreal injectable, one time only.
Trial: NCT05108350
Drug: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: SHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment T1 followed by 7 days washout and then receive treatment R1+R.
Trial: NCT05108350
Drug: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment T2 followed by 7 days washout and then receive treatment R2+R.
Trial: NCT05108350
Drug: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment R2+R followed by 7 days washout and then receive treatment T2.
Trial: NCT04940286
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT04940286
Drug: Nab-paclitaxel
RxNorm normalized name: NAB-PACLITAXEL COMPONENT PACLITAXEL
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given IV
Trial: NCT04796623
Drug: Fulvestrant injection
RxNorm normalized name: Fulvestrant Injection
DrugBank: Fulvestrant (DB00947)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.
Trial: NCT04738149
Drug: Bimatoprost
RxNorm normalized name: Bimatoprost
DrugBank: Bimatoprost (DB00905)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Participants will be receiving 2 drops per 4cm2 twice a week for 12 weeks
Trial: NCT06667349
Drug: Ticagrelor
RxNorm normalized name: Ticagrelor
DrugBank: Ticagrelor (DB08816)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ticagrelor 90 mg PO BID given for atleast two weeks following primary PCI
Trial: NCT05622058
Drug: TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
RxNorm normalized name: Triamcinolone
DrugBank: Triamcinolone (DB00620)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: TAC will be administered as an IV infusion on Day 1 of every 3-week treatment cycle
Trial: NCT04865744
Drug: Semaglutide 7 MG Oral Tablet
RxNorm normalized name: semaglutide 7 MG Oral Tablet
DrugBank: Semaglutide (DB13928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water.
Trial: NCT04865744
Drug: Semaglutide 14 MG Oral Tablet
RxNorm normalized name: semaglutide 14 MG Oral Tablet
DrugBank: Semaglutide (DB13928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water.
Trial: NCT06191328
Drug: Chiglitazar sodium
RxNorm normalized name: Chiglitazar
DrugBank: Chiglitazar (DB19023)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: In patients with type 2 diabetes mellitus (T2DM), on the basis of one or two oral hypoglycemic agents combination with Chiglitazar sodium.
Trial: NCT05052398
Drug: PSP NEURO SERUM
RxNorm normalized name: Serum, horse
DrugBank: Serum, horse (DB14613)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: PSP NEURO SERUM is a topical product that contains a concentration of Paralytic Shellfish Toxins of 10 micrograms/mL of equivalent of Gonyautoxin 2/3. Each patient will apply 1 g of PSP NEURO SERUM in their hands, three times a day.
Trial: NCT01302106
Drug: Clofarabine plus low dose Ara-C
RxNorm normalized name: cytarabine
DrugBank: Clofarabine (DB00631)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Clofarabine 10 mg/m2 by a 1-hr i.v infusion, once daily, from day 1 to 5. Ara-C 10 mg/m2, subcutaneously, twice a day (q12 hrs), from day 1 to 15. Clofarabine will be given 4 hours before the 2nd dose of Ara-C.
Trial: NCT06665217
Drug: Glofitamab, Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Prednisone as Induction Therapy
DrugBank: Lenalidomide (DB00480)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patients were treated by Glofitama(Cycle 1: D8, 2.5mg, D15, 10mg; followed by the target dose of 30mg on D1 of Cycle 2-12), Polatuzumab Vedotin(1.8mg/kg iv qd d1), Zanubrutinib(160mg po bid d1-21), Lenalidomide(25mg po qd d1-14) and Prednisone(60mg/m2 po qd d1-5) as induction therapy.
Trial: NCT05162625
Drug: Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution
RxNorm normalized name: moxifloxacin ophthalmic 0.5% ophthalmic solution
DrugBank: Moxifloxacin (DB00218)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Topical moxifloxacin 0,5% 01 drop every 3 hours
Trial: NCT05162625
Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV]
RxNorm normalized name: Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV]
DrugBank: Ciprofloxacin (DB00537)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intravenous ciprofloxacin 400mg every 12 hours and cefazolin 1000mg every 6 hours
Trial: NCT06624319
Drug: Dexmedetomidine as adjuvent to bupvacaine in tap block
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: The analgesic effect of Two different doses of dexmedetomidine as adjuvent to bupivacaine in tap block
Trial: NCT05325489
Drug: Nebulized Budesonide
RxNorm normalized name: Budesonide
DrugBank: Budesonide (DB01222)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD
Trial: NCT05325489
Drug: Intranasal Budesonide Spray
RxNorm normalized name: budesonide Nasal Spray
DrugBank: Budesonide (DB01222)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD
Trial: NCT04922151
Drug: 601
RxNorm normalized name: TM 601
DrugBank: Chlorotoxin (DB15210)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: intravitreal recombinant humanized anti-VEGF monoclonal antibody
Trial: NCT04922151
Drug: Ranibizumab
RxNorm normalized name: Ranibizumab
DrugBank: Ranibizumab (DB01270)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: intravitreal recombinant humanized anti-VEGF monoclonal antibody
Trial: NCT05323617
Drug: Romiplostim
RxNorm normalized name: Romiplostim
DrugBank: Romiplostim (DB05332)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Administered as a subcutaneous injection.
Trial: NCT05323617
Drug: Antithymocyte Globulin
RxNorm normalized name: Rabbit antithymocyte globulin
DrugBank: Antithymocyte immunoglobulin (rabbit) (DB00098)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Horse or rabbit antithymocyte globulin administered as an intravenous infusion.
Trial: NCT05323617
Drug: Cyclosporine A
RxNorm normalized name: CycloSPORINE A
DrugBank: Cyclosporine (DB00091)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally.
Trial: NCT06495203
Drug: anti-VEGF treatment
RxNorm normalized name: Anti-VEGF monoclonal antibody
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Follow clinical practice/administration
Trial: NCT04799379
Drug: microporous polysaccharide hemospheres (MPH) agent in rectal surgery
DrugBank: Poly(lactic acid) (DB15037)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Use of microporous polysaccharide hemospheres (MPH) agent in patients after rectal surgery to avoid pelvic collections and the use of any drain
Trial: NCT00001016
Drug: Trimetrexate glucuronate
RxNorm normalized name: Trimetrexate Glucuronate
DrugBank: Trimetrexate (DB01157)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT05994963
Drug: sisunatovir
RxNorm normalized name: Sisunatovir
DrugBank: Sisunatovir (DB15674)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered as either capsules in fasted state or tablet in fasted or fed state.
Trial: NCT06052423
Drug: HS-20093
RxNorm normalized name: HS-CoM
DrugBank: Coenzyme M (DB09110)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells.
Trial: NCT04863339
Drug: Tranexamic acid
RxNorm normalized name: Tranexamic Acid
DrugBank: Tranexamic acid (DB00302)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.
Trial: NCT06194695
Drug: envatinib plus anti-PD(L)1
RxNorm normalized name: Anti-PD1 / CTLA4 Bispecific Antibody XmAb20717
DrugBank: Vudalimab (DB18833)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral use of lenvatinib plus intravenous injection of anti-PD(L)1 antibodies. Anti-PD-L1 antibodies includes duravalumab, atezolizumab, or envolizumab, and anti-PD1 antibodies include pembrolizumab, nivolumab, camrelizumab, tislelizumab, sintilimab, or toripalimab.
Trial: NCT06157099
Drug: Atorvastatin
RxNorm normalized name: Atorvastatin
DrugBank: Atorvastatin (DB01076)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT05557695
Drug: Acalabrutinib
RxNorm normalized name: Acalabrutinib
DrugBank: Acalabrutinib (DB11703)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Acalabrutinib
Trial: NCT06231693
Drug: Trastuzumab deruxtecan
RxNorm normalized name: Trastuzumab deruxtecan
DrugBank: Trastuzumab deruxtecan (DB14962)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patients with RE\<10% and HER2-Low breast cancer that have received Trastuzumab-deruxtecan in the metastatic setting
Trial: NCT06463444
Drug: HAIC + Tislelizumab +lenvatinib
RxNorm normalized name: Tislelizumab
DrugBank: Lenvatinib (DB09078)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: All patients were treated with HAIC combined with tislelizumab and lenvatinib.~1. HAIC was adopted of the FOFOLX 6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days.~2. Lenvatinib was started before HAIC treatment, discontinued during HAIC treatment, Oral 8 mg or 12mg once a day depending body weight.~3. First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later.
Trial: NCT05968768
Drug: Naxitamab
RxNorm normalized name: Naxitamab
DrugBank: Naxitamab (DB15965)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Naxitamab will be used only in a hospital setting and must be administered under the supervision of a doctor with experience in the use of oncological therapies. The medicinal product must be administered by a healthcare professional prepared to deal appropriately with severe allergic reactions, including anaphylaxis, in an environment that provides immediate, full access to resuscitation. The patient should have 2 well-functioning IV accesses before any naxitamab treatment is initiated. The solution should be administered through a peripheral or central intravenous catheter. Other concomitant intravenous medicinal products should be administered through separate intravenous access. Before the start of each infusion, premedication will be carried out.
Trial: NCT05354102
Drug: Nivolumab
RxNorm normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: A human monoclonal antibody that blocks programmed-death-1 (PD-1). It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
Trial: NCT04850261
Drug: hCG Injection
DrugBank: Chorionic Gonadotropin (Human) (DB09126)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ovulation will be induced by subcutaneous hCG injection
Trial: NCT04850261
Drug: Nafarelin nasal spray
RxNorm normalized name: nafarelin Metered Dose Nasal Spray
DrugBank: Nafarelin (DB00666)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ovulation will be induced by nasal application of Nafarelin
Trial: NCT06322095
Drug: PD-1
RxNorm normalized name: NPD-1
DrugBank: PD-168393 (DB07662)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Previous PD-1
Trial: NCT06322095
Drug: ALK inhibitor
RxNorm normalized name: an orally bioavailable ALK inhibitor (a macrocyclic compound containing nitrogen heterocycles)
DrugBank: NVL-655 (DB18682)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Previous ALK inhibitor
Trial: NCT06322095
Drug: EGFR Monoclonal antibody
RxNorm normalized name: Anti-VEGF monoclonal antibody
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Previous EGFR Monoclonal antibody
Trial: NCT06322095
Drug: GH21
RxNorm normalized name: Somatropin
DrugBank: Somatotropin (DB00052)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral, 15mg BIW or 6mg QD
Trial: NCT05543109
Drug: Propofol
RxNorm normalized name: Propofol
DrugBank: Propofol (DB00818)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 3mg/kg during induction of anesthesia
Trial: NCT05543109
Drug: Rocuronium
RxNorm normalized name: Rocuronium
DrugBank: Rocuronium (DB00728)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 0.9 mg/kg during induction of anesthesia
Trial: NCT05543109
Drug: Sevoflurane
RxNorm normalized name: Sevoflurane
DrugBank: Sevoflurane (DB01236)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 2-3% during maintanance of anesthesia
Trial: NCT05543109
Drug: Ropivacaine
RxNorm normalized name: Ropivacaine
DrugBank: Ropivacaine (DB00296)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 0.25% Ropivacaine will be used at 1 ml/kg will be injected Ultrasound guided after induction of general anesthesia.
Trial: NCT05292066
Drug: Duloxetine Tablets,
DrugBank: Duloxetine (DB00476)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Duloxetine is an FDA-approved medication used to treat the major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain. It is taken by mouth. It is a serotonin-norepinephrine reuptake inhibitor.~Pregabalin is an FDA approved, sold under the brand name Lyrica. it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome,
Trial: NCT05292066
Drug: Pregabalin Tablets
RxNorm normalized name: Pregabalin
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pregabalin is an FDA approved, it is an anticonvulsant and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome,
Trial: NCT06013943
Drug: Envafolimab+Gemox
RxNorm normalized name: Hemox A
DrugBank: Envafolimab (DB15769)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All of drugs were used for 6-8 cycles at the combined treatment stage, then Envafolimab and Gemcitabine continued at maintenance treatment stage until disease progression as defined by RECIST1.1, unacceptable toxicity, withdrawal from the study or death, or no more than 1 years.~Combined treatment stage: Envafolimab(150mg, iH, Q1W, Day1)+Gemcitabine(1000mg/m2, iv, Q3W, Day1 and Day8)+Cisplatin(1000mg/m2, iv, Q3W, Day1 and Day8);~Caintenance treatment stage: Envafolimab(400mg, iH, Day1, Q3W)+Gemcitabine(1000mg/m2, po, Day1-14, Q3W).
Trial: NCT05213195
Drug: NKG2D CAR-NK
RxNorm normalized name: NKG2D CAR-NK Cell
DrugBank: NKG2D-ACE2 CAR-NK Cell (DB15727)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: NKG2D CAR-NK infusion through peritoneal in stage 1 and later combined with intra venous in stage 2.
Trial: NCT05413200
Drug: Isotretinoin
RxNorm normalized name: Isotretinoin
DrugBank: Isotretinoin (DB00982)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: oral isotretinoin with a standard dose regime for 90 days
Trial: NCT03915678
Drug: Association atezolizumab + BDB001 + RT
RxNorm normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).~BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.~Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
Trial: NCT03915678
Drug: Association atezolizumab + BDB001+ RT
RxNorm normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).~BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.~Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
Trial: NCT05245916
Drug: IBI397+Sintilimab
RxNorm normalized name: Sintilimab
DrugBank: Sintilimab (DB15765)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IBI397 in combination with sintilimab： Subjects will receive IBI397 combination therapy with sintilimab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
Trial: NCT05245916
Drug: IBI397+Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: IBI397 in combination with rituximab： Subjects will receive IBI397 combination therapy with rituximab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
Trial: NCT04945421
Drug: Sintilimab
RxNorm normalized name: Sintilimab
DrugBank: Sintilimab (DB15765)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: (IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
Trial: NCT05771896
Drug: Darolutamide
RxNorm normalized name: DAROLUTAMIDE
DrugBank: Darolutamide (DB12941)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will continue treatment with darolutamide until radiological progression, withdrawal, death, termination, or study completion.~The maximum time for darolutamide dose interruption period is 28 consecutive days beyond scheduled dose (\>56 days between cycles). Any participant requiring dose interruption \>28 consecutive days beyond the scheduled dose may restart treatment with darolutamide if clinical benefit is anticipated and after discussion with and approval from the study Medical Monitor.~Until primary endpoint is reached, participants are not allowed to switch ARPI (Abiraterone, Apalutamide or Enzalutamide) during the study. Switching to other ARPI following radiographic progression should be considered a subsequent life prolonging therapy and documented accordingly.
Trial: NCT05771896
Drug: Radium-223
RxNorm normalized name: Radium-223
DrugBank: Radium Ra-223 (DB12813)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Radium-223 should be given for 6 cycles, administered IV on Day 1 of each cycle or until radiological progression, withdrawal, death, termination, or study completion. The placebo will be administered in precisely the same fashion as the active drug.~Subsequent cycles 2-6 should be scheduled to occur every 28 ± 7 days following the previous cycle, but dosing may be delayed up to 28 days per cycle (maximum 56 days between cycles). Any participant requiring dose interruption \>28 consecutive days (\>56 days between cycles) may restart treatment with radium-223/placebo if clinical benefit is anticipated and after discussion with the Medical Monitor. Participants will continue with darolutamide irrespective of Radium-223 administration.~Upon radiological progression, further treatments are decided by the site investigator according to standard local practice.
Trial: NCT05545800
Drug: metformin+empagliflozin+insulin glargine
RxNorm normalized name: empagliflozin / metformin
DrugBank: Insulin glargine (DB00047)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Randomization was performed with the use of a computer-generated system provided by the sponsor. The dose of metformin will be initiated at 0.5 grams three times a day (the maximum dose is 2g/day); the dose of empagliflozin will be 10 milligrams once a day; insulin glargine will be received once daily at bedtime and the dose will be initiated at the 50% of 0.4-0.5 units/kg/day. All groups received counseling on lifestyle modification.