TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT06522828
Drug: carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: chemotherapy
Study: NCT06522828
Drug: paclitaxel
Normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: chemotherapy
Study: NCT05538663
Drug: Gemcitabine
Normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years
Study: NCT05538663
Drug: Docetaxel
Normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years
Study: NCT06155396
Drug: Disitamab Vedotin
Normalized name: Disitamab vedotin
DrugBank: Disitamab vedotin (DB17208)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2.0 mg/kg IV every 2 weeks
Study: NCT06155396
Drug: Zimberelimab
Normalized name: Zimberelimab
DrugBank: Zimberelimab (DB17505)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 240mg IV every 2 weeks
Study: NCT06220942
Drug: Phenylephrine
Normalized name: Phenylephrine
DrugBank: Phenylephrine (DB00388)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Pregnant female presented for C.S. after receiving spinal anesthesia, recording the vital data, phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases ≥ 20 % of baseline
Study: NCT05948826
Drug: TORL-3-600
Normalized name: TORL-2-307
DrugBank: TORL-2-307 (DB18376)
Approvals — FDA: no, EMA: no, PMDA: no
Description: antibody drug conjugate
Study: NCT06017362
Drug: Insulin
Normalized name: Insulin
DrugBank: Insulin human (DB00030)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Topical insulin 1UI/ml 4 times a day
Study: NCT06017362
Drug: Artificial tear
Normalized name: Artificial Tears
DrugBank: Propylene glycol (DB01839)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Artificial tears 4 times a day
Study: NCT00000991
Drug: Pentamidine isethionate
Normalized name: Pentamidine Isethionate
DrugBank: Pentamidine (DB00738)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00000991
Drug: Sulfamethoxazole-Trimethoprim
Normalized name: sulfamethoxazole-trimethoprim
DrugBank: Trimethoprim (DB00440)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00000991
Drug: Dapsone
Normalized name: Dapsone
DrugBank: Dapsone (DB00250)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00000991
Drug: Zidovudine
Normalized name: Zidovudine
DrugBank: Zidovudine (DB00495)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT05889052
Drug: Sulfadoxine pyrimethamine
Normalized name: pyrimethamine / sulfadoxine
DrugBank: Pyrimethamine (DB00205)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets (Macleods Pharmaceuticals Ltd)
Study: NCT04755088
Drug: Surufatinib
Normalized name: Surufatinib
DrugBank: Surufatinib (DB15106)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects to receive Surufatinib 300mg on Day 1
Study: NCT06385678
Drug: HRS-4642
Normalized name: HRS-1167
DrugBank: HRS-1167 (DB18703)
Approvals — FDA: no, EMA: no, PMDA: no
Description: administrated per dose level in which the patients are assigned
Study: NCT06385678
Drug: Adebrelimab
Normalized name: Adebrelimab
DrugBank: Adebrelimab (DB16412)
Approvals — FDA: no, EMA: no, PMDA: no
Description: administrated per dose level in which the patients are assigned
Study: NCT06385678
Drug: SHR-9839
Normalized name: SHR-A1904
DrugBank: SHR-A1904 (DB18702)
Approvals — FDA: no, EMA: no, PMDA: no
Description: administrated per dose level in which the patients are assigned
Study: NCT06385678
Drug: Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: administered as prescribed by the investigator.
Study: NCT06385678
Drug: Cetuximab Solution for Infusion
Normalized name: Cetuximab
DrugBank: Cetuximab (DB00002)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: administrated per dose level in which the patients are assigned
Study: NCT05549752
Drug: Flecainide Injectable Solution
Normalized name: flecainide Injectable Solution
DrugBank: Flecainide (DB01195)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intravenous Flecainide at a dose of 2.0mg/kg (maximum dose: 150mg) in 100ml D/W 5% for 10 minutes.
Study: NCT05549752
Drug: Amiodarone Injectable Solution
Normalized name: amiodarone Injectable Solution
DrugBank: Amiodarone (DB01118)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intravenous Amiodarone at a dose of 5.0-7.0 mg/kg for 1 hour, and maintenance dose of 50mg/h (maximum dose: 1000mg) for up to 24 hours.
Study: NCT04595682
Drug: Alcohol
Normalized name: Alcohol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants will attend two identical laboratory sessions to test sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol, once during the early follicular phase and once during the late follicular phase. The test battery consists of measures of rewarding effects and alcohol effects on disinhibition and impulsive choice. The alcohol dose consists of 0.60 g/kg absolute alcohol that produces a peak blood-alcohol concentration of 80 mg/dl. Doses will be mixed with a carbonated, non-caffeinated, lemon-flavored soda and consumed within 10 minutes.
Study: NCT04954820
Drug: Lutathera
Normalized name: Lutathera
DrugBank: Lutetium Lu 177 dotatate (DB13985)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2 additional infusions of Lutathera®
Study: NCT05067140
Drug: ARV-766 + Abiraterone Part C&D
DrugBank: Abiraterone (DB05812)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part C: Daily oral combination dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.~Part D: Combination administered once daily in 28 day cycles.~Parts C\&D: Participants will also receive concomitant corticosteroid and ADT therapy of investigator choice/patient preference
Study: NCT05150899
Drug: Tamsulosin Hcl 0.4Mg Cap
Normalized name: TAMSULOSIN HCL 0.4MG CAP
DrugBank: Tamsulosin (DB00706)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: alpha blocker
Study: NCT05150899
Drug: fexofenadine 180 mg Oral tablet
Normalized name: fexofenadine 180 mg oral tablet
DrugBank: Fexofenadine (DB00950)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: antihistaminic
Study: NCT04712058
Drug: Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy]
Normalized name: bictegravir / emtricitabine / tenofovir alafenamide Oral Tablet [Biktarvy]
DrugBank: Emtricitabine (DB00879)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Biktarvy will be administered on the same day of diagnosis. The daily dosing will be continued for 48 weeks.
Study: NCT06378112
Drug: GTO®
Normalized name: Glatiramer Acetate
DrugBank: Glatiramer (DB05259)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: After teeth extraction, a guided bone regeneration procedure will be performed using a bone graft and a soft collagenated cortical membrane as graft stabilizer. Implant placement surgery will also be performed.
Study: NCT04283513
Drug: Virazole
Normalized name: Virazole
DrugBank: Ribavirin (DB00811)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Virazole (Ribavirin), USP Injection 0.1 g/mL in a phosphate buffer solution. Each vial contains 1.2 g of Ribavirin in 12 mL
Study: NCT06145308
Drug: Vedolizumab
Normalized name: Vedolizumab
DrugBank: Vedolizumab (DB09033)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma (HER2 expression group) : Vedicetumab (2.5mg/kg, Q2w) alone or combined with platinum-based chemotherapy drugs (carboplatin 200-250mg/m2, Q2w or cisplatin 50mg/m2, Q2w) Rescue therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma that cannot tolerate or refuse surgery and is rapidly progressing (HER2 expression group) : Vedicetumab monotherapy (2mg/kg, IV, Q2w) or vedicetumab (2mg/kg, IV, Q2w) combined with immune checkpoint inhibitors (triprilizumab 3mg/kg, IV, Q2w, etc.) or vedicetumab (2mg/kg, IV, Q2W, etc.) Q2w) in combination with oral HER2 TKI (pyrrotinib 400mg po qd and other drugs) or Vedicetsol in combination with platinum-based chemotherapy drugs of the doctor's choice (carboplatin 200-250mg/m2, intravenous drip, Q2w or cisplatin 50mg/m2, intravenous drip, Q2w).
Study: NCT06145308
Drug: albumin paclitaxel with platinum
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Neoadjuvant and translational studies in patients with locally advanced/recurrent and advanced oligometastatic salivary gland carcinoma(no target and other groups) : albumin paclitaxel :160mg/m2 Q2w or 260mg/m2 Q3w, combined with platinum-based chemotherapy drugs of the doctor's choice: cisplatin 50mg/m2, Q2w or 75mg/m2, Q3w, or carboplatin 200-250mg/m2 Q2w or 350mg/m2 q3w, ; Rescue therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma that cannot tolerate or refuse surgery and is rapidly progressing(no target and other groups) : albumin paclitaxel :160mg/m2 Q2w or 260mg/m2 Q3w, combined with platinum-based chemotherapy drugs of the doctor's choice: cisplatin 50mg/m2, Q2w or 75mg/m2, Q3w, or carboplatin 200-250mg/m2 Q2w or 350mg/m2 q3w,
Study: NCT05480111
Drug: Local anesthesia at incision site
Normalized name: rose bengal AT
DrugBank: Rose bengal (DB11182)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 20 ml of 0.25% Bupivacaine will be given at incision site
Study: NCT05480111
Drug: Sham QL
Normalized name: BLACK BEAN ANTI HAIR LOSS SHAM POO SET KIT
DrugBank: Bean (DB14709)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia
Study: NCT05480111
Drug: QL
Normalized name: Qlosi
DrugBank: Pilocarpine (DB01085)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia
Study: NCT05976347
Drug: Duloxetine 30 MG
Normalized name: duloxetine 30 MG
DrugBank: Duloxetine (DB00476)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Duloxetine 30 mg once daily
Study: NCT05891795
Drug: Clascoterone 1% Top Cream
Normalized name: CLASCOTERONE 1% TOP CREAM
DrugBank: Clascoterone (DB12499)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Apply a thin layer to the affected area twice daily.
Study: NCT04966663
Drug: Nivolumab
Normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Antineoplastic agent
Study: NCT04966663
Drug: Pemetrexed
Normalized name: Pemetrexed
DrugBank: Pemetrexed (DB00642)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Antineoplastic agent
Study: NCT04966663
Drug: Gemcitabine
Normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Antineoplastic agent
Study: NCT04966663
Drug: Cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Antineoplastic agent
Study: NCT04966663
Drug: Carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Antineoplastic agent
Study: NCT06196671
Drug: Camrelizumab
Normalized name: Camrelizumab
DrugBank: Camrelizumab (DB14776)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.
Study: NCT06108544
Drug: TAK-279
Normalized name: TAK-243
DrugBank: TAK-243 (DB15013)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Specified drug on specified days.
Study: NCT06108544
Drug: Apremilast
Normalized name: Apremilast
DrugBank: Apremilast (DB05676)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Specified drug on specified days.
Study: NCT05660980
Drug: Once daily CAB tablet + RPV tablet
Normalized name: gabapentin
DrugBank: Gabapentin (DB00996)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Tablet
Study: NCT04667507
Drug: Dexamethasone Ophthalmic implant
Normalized name: dexamethasone Drug Implant
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use
Study: NCT05648032
Drug: triamcinolone acetonide 10mg
Normalized name: TRIAMCINOLONE ACETONIDE 10MG/ML INJ,SUSP
DrugBank: Triamcinolone (DB00620)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ultrasound-guided injection of 1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide into the hypoechoic area of common extensor tendon (in lateral epicondylopathy) or around calcific spots (in supraspinatus calcific tendinitis)
Study: NCT04895241
Drug: Litifilimab
Normalized name: Litifilimab
DrugBank: Litifilimab (DB18864)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered as specified in the treatment arm.
Study: NCT06059118
Drug: DFMO
Normalized name: DFMO
DrugBank: Eflornithine (DB06243)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Each 119 day cycle, Days 1-7 patient will take 1000 mg by mouth (PO) twice a day (bid), and then on Day 8 - 63 patient will take 1000 mg PO bid while receiving high dose testosterone IM on Day 8 and Day 36 of cycle.
Study: NCT06059118
Drug: testosterone cypionate
Normalized name: Testosterone Cypionate
DrugBank: Testosterone cypionate (DB13943)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: On Day 8 and Day 36 of each 119 day cycle, patient will receive high dose testosterone at 400 mg through intramuscular (IM) injection.
Study: NCT06059118
Drug: Luteinizing hormone-releasing hormone (LHRH) analogue
DrugBank: Lutein (DB00137)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients who have progressive disease after treatment with Abiraterone (Abi) will continue with androgen depravation therapy (ADT) with LHRH analogue (LHRH agonist drug (i.e. Zoladex, Trelstar, Eligard or Lupron) or LHRH antagonist drug (Degarelix or Relugolix)). Dosing instructions will vary between the different LHRH analogues. Patients should follow the dosing instructions as directed by their physician.
Study: NCT06059118
Drug: Enzalutamide
Normalized name: Enzalutamide
DrugBank: Enzalutamide (DB08899)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Each 119 day cycle, Days 64-119 patient will take 160 mg by mouth (PO) once a day (qd).
Study: NCT05346666
Drug: Tocilizumab Prefilled Syringe [Actemra]. propofole, phenobarbital, midazolam
DrugBank: Midazolam (DB00683)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Tocilizumab is an immuno-modulatory drug which act as interleukin (IL)-6 receptor inhibitor that blocks IL-6-mediated signal transduction. This drug is known to improve various diseases
Study: NCT00002271
Drug: Alovudine
Normalized name: Alovudine
DrugBank: Alovudine (DB06198)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT06109961
Drug: Oxygen Gas for Inhalation
Normalized name: oxygen Gas for Inhalation
DrugBank: Oxygen (DB09140)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM).
Study: NCT06650501
Drug: Dabigatran
Normalized name: Dabigatran
DrugBank: Dabigatran (DB14726)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will be assigned to change to dabigatran at the monograph approved dose for their indication, bleeding risk, and renal function.
Study: NCT06650501
Drug: Apixaban
Normalized name: Apixaban
DrugBank: Apixaban (DB06605)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban
Study: NCT06650501
Drug: edoxaban
Normalized name: Edoxaban
DrugBank: Edoxaban (DB09075)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban
Study: NCT06650501
Drug: Rivaroxaban
Normalized name: Rivaroxaban
DrugBank: Rivaroxaban (DB06228)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban
Study: NCT05437497
Drug: Remimazolam Injection
Normalized name: remimazolam Injection
DrugBank: Remimazolam (DB12404)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: The experimental group was sedated with remimazolam
Study: NCT05437497
Drug: Propofol Injection
Normalized name: propofol Injection
DrugBank: Propofol (DB00818)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The control group was sedated with propofol
Study: NCT05954871
Drug: GDC-1971
Normalized name: GDC-1971
DrugBank: GDC-1971 (DB17487)
Approvals — FDA: no, EMA: no, PMDA: no
Description: GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
Study: NCT05954871
Drug: Osimertinib
Normalized name: Osimertinib
DrugBank: Osimertinib (DB09330)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Osimertinib tablets will be administered as specified in each treatment arm.
Study: NCT05954871
Drug: Cetuximab
Normalized name: Cetuximab
DrugBank: Cetuximab (DB00002)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Cetuximab, solution for infusion will be administered as specified in each treatment arm.
Study: NCT05863416
Drug: Dexmedetomidine infusion
DrugBank: Dexmedetomidine (DB00633)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Intraoperative dexmedetomidine infusion
Study: NCT06308588
Drug: Blinatumomab
Normalized name: Blinatumomab
DrugBank: Blinatumomab (DB09052)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given by Infusion
Study: NCT06308588
Drug: Asciminib
Normalized name: Asciminib
DrugBank: Asciminib (DB12597)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Given by PO
Study: NCT05456191
Drug: Asciminib
Normalized name: Asciminib
DrugBank: Asciminib (DB12597)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Asciminib 80 mg QD administered under fasting conditions.
Study: NCT05456191
Drug: Nilotinib
Normalized name: Nilotinib
DrugBank: Nilotinib (DB04868)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Nilotinib 300 mg BID administered under fasting conditions.
Study: NCT05789069
Drug: Tislelizumab
Normalized name: Tislelizumab
DrugBank: Tislelizumab (DB14922)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will be administered tislelizumab as described in the experimental arm.
Study: NCT05464433
Drug: Tislelizumab combined with Liposomal mitoxantrone hydrochloride
Normalized name: Tislelizumab
DrugBank: Mitoxantrone (DB01204)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Drug: liposomal mitoxantrone hydrochloride, tislelizumab Drug: Liposomal mitoxantrone hydrochloride (16 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.~Drug: tislelizumab(200 mg) will be taken orally on day 1 of each 28-day cycle.
Study: NCT05464433
Drug: Maintenance of tislelizumab
Normalized name: Tislelizumab
DrugBank: Tislelizumab (DB14922)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug: tislelizumab(200 mg) will be taken orally on day 1 of each 21-day cycle
Study: NCT06023641
Drug: Vincristine
Normalized name: Vincristine
DrugBank: Vincristine (DB00541)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Low -risk Administer IV push over 1 minute (or infusion via minibag as per institutional standards) on Day 1 of Weeks 1,8, 15 (3) doses. The maximum dose is 2 mg for all participants.~Intermediate-risk Administer IV, over 1 minute, 3 doses, weekly on day1 High-risk Administer by IV infusion over 1 minute, 3 doses, weekly on day 1,8,15
Study: NCT06023641
Drug: Dactinomycin
Normalized name: Dactinomycin
DrugBank: Dactinomycin (DB00970)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Low-risk Administer by slow IV push over 1-5 minutes on Day 1 of Weeks 1, (1) dose. The maximum dose is 2.5 mg for all participants.~Intermediate-risk Administer by slow IV over 1-5 minutes., 1 doses weekly on day 1 High-risk Administer by slow IV over 1-5 minutes, day1
Study: NCT06023641
Drug: Vinorelbine
Normalized name: Vinorelbine
DrugBank: Vinorelbine (DB00361)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intermediate and High-risk Administer via slow IV push over 6-10 minutes (or infusion via minibag as per institutional standards) on Day 1 of Weeks 43-45, 47-49, 51-53, 55-57, 59-61, 63-65.
Study: NCT05380479
Drug: Mirtazapine
Normalized name: Mirtazapine
DrugBank: Mirtazapine (DB00370)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: mirtazaine15 mg tablet daily for 8 weeks.
Study: NCT05380479
Drug: Megestrol Acetate
Normalized name: Megestrol Acetate
DrugBank: Megestrol acetate (DB00351)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: megestrol acetate 160 mg tablet daily for 8 weeks.
Study: NCT06023641
Drug: Temozolomide
Normalized name: Temozolomide
DrugBank: Temozolomide (DB00853)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: High-risk Administer PO (or by NG or G tube) 5 doses, on Days 1-5 When administering with liposomal irinotecan, administer temozolomide prior to liposomal irinotecan. Preferably, administer on an empty stomach (at least 1 hour before and 2 hours after food) to improve absorption. When using temozolomide capsules, round dose to the nearest 5 mg capsule. The capsule may be opened, and contents mixed with applesauce or apple juice. A compounded oral suspension is also available. If emesis occurs within 20 minutes of taking a dose of temozolomide, then the dose may be repeated once.
Study: NCT05457829
Drug: Temozolomide+Irinotecan+Vincristine
DrugBank: Vincristine (DB00541)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Q3W, 2 cycles.
Study: NCT06023641
Drug: Filgrastim, peg-filgrastim
DrugBank: Filgrastim (DB00099)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Low, Intermediate and High-risk:~Prophylactic myeloid growth factor support (Filgrastim or Pegfilgrastim) should be used after all VAC cycles for patients on the high-risk arm. Start myeloid growth factor support (for example, filgrastim 5 mcg/kg/dose SubQ daily until the ANC is ≥ 2000/μL after the expected nadir OR pegfilgrastim 0.1 mg/kg/dose \[for patients \< 45 kg\] or 6 mg/dose \[for patients ≥ 45 kg\] SubQ x 1 dose) 24-48 hours after VAC cycles. Filgrastim may be continued without regard to VCR. Discontinue filgrastim at least 24 hours before the start of the next cycle. Prophylactic myeloid growth factor support should NOT be used after VLIT cycles or during maintenance chemotherapy.