AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT06456515
Drug: Regorafenib and Sintilimab in combination with electroacupuncture
RxNorm normalized name: Regorafenib
DrugBank: Regorafenib (DB08896)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Regorafenib, take for 2 weeks and stop for 1 week; Sintilimab, intravenous, every 3 weeks; Electroacupuncture was performed 1 day before, on the day of, and on the 2nd day after each cycle of Sintilimab administration, and patients completed 3 treatments in week 1, followed by 1 treatment per week for 2 weeks, with 5 treatments per dosing cycle.
Trial: NCT05019885
Drug: Ketamine Hydrochloride
RxNorm normalized name: Ketamine Hydrochloride
DrugBank: Ketamine (DB01221)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Three times a week (M, W, F) for 2 consecutive weeks.
Trial: NCT06511037
Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
DrugBank: Pafolacianine (DB15413)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT02522611
Drug: Resiniferatoxin
RxNorm normalized name: resiniferatoxin
DrugBank: Resiniferatoxin (DB06515)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Resiniferatoxin (RTX) is an ultrapotent agonist analog of capsaicin that targets a receptor expressed on specific dorsal root sensory ganglia (DRG) neurons and is expected to reduce pain within the targeted zone.
Trial: NCT06486051
Drug: Fludarabine
RxNorm normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 30 mg/m\^2/day IV for three consecutive days
Trial: NCT04708054
Drug: Busulfan
RxNorm normalized name: Busulfan
DrugBank: Busulfan (DB01008)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT04708054
Drug: Cladribine
RxNorm normalized name: Cladribine
DrugBank: Cladribine (DB00242)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT04708054
Drug: Fludarabine Phosphate
RxNorm normalized name: Fludarabine Phosphate
DrugBank: Fludarabine (DB01073)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT04708054
Drug: Thiotepa
RxNorm normalized name: Thiotepa
DrugBank: Thiotepa (DB04572)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given IV
Trial: NCT04708054
Drug: Venetoclax
RxNorm normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given PO
Trial: NCT06240754
Drug: Enasidenib
RxNorm normalized name: Enasidenib
DrugBank: Enasidenib (DB13874)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Provided by BMS.
Trial: NCT04728711
Drug: ADX-629
RxNorm normalized name: ADX 102
DrugBank: Reproxalap (DB16688)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week
Trial: NCT05662098
Drug: Hydroxyurea
RxNorm normalized name: Hydroxyurea
DrugBank: Hydroxyurea (DB01005)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All participants will receive an individualized PK hydroxyurea assessment. Participants for whom the PK-process successfully generates a dose in the predicted treatment range of 15-35 mg/kg/day, will start on that personalized dose. Participants for whom the process does not generate a starting hydroxyurea dose in the predicted treatment range, due to potential pitfalls in lab draws, serum storage, sample processing, or hydroxyurea analysis, will start at a default dose of 20.0 ± 2.5 mg/kg/day. For all participants, the hydroxyurea dose will be adjusted as needed based on blood counts to establish the optimal dose. Where necessary, a weekly dosing average will be determined, so that treatment can occur solely with locally available and affordable 500mg hydroxyurea capsules.
Trial: NCT06412198
Drug: Cetuximab
RxNorm normalized name: Cetuximab
DrugBank: Cetuximab (DB00002)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Given by IV
Trial: NCT06412198
Drug: Cemiplimab
RxNorm normalized name: CEMIPLIMAB
DrugBank: Cemiplimab (DB14707)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given by IV
Trial: NCT06412198
Drug: Adagrasib
RxNorm normalized name: Adagrasib
DrugBank: Adagrasib (DB15568)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given by PO
Trial: NCT05606341
Drug: CpG1018
RxNorm normalized name: hepatitis B vaccine/CpG1018/PF 20 mcg/0.5 mL INTRAMUSC VIAL (ML)
DrugBank: Hepatitis B Vaccine (Recombinant) (DB11627)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.1 mg/kg dose administered via subcutaneous injection.~TLR9 agonist supplied by Dynavax Technologies Inc.
Trial: NCT05606341
Drug: CpG1018
RxNorm normalized name: hepatitis B vaccine/CpG1018/PF 20 mcg/0.5 mL INTRAMUSC VIAL (ML)
DrugBank: Hepatitis B Vaccine (Recombinant) (DB11627)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.25 mg/kg dose administered via subcutaneous injection.~TLR9 agonist supplied by Dynavax Technologies Inc.
Trial: NCT05606341
Drug: CpG1018
RxNorm normalized name: hepatitis B vaccine/CpG1018/PF 20 mcg/0.5 mL INTRAMUSC VIAL (ML)
DrugBank: Hepatitis B Vaccine (Recombinant) (DB11627)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 0.5 mg/kg dose administered via subcutaneous injection.~TLR9 agonist supplied by Dynavax Technologies Inc.
Trial: NCT06506422
Drug: Empagliflozin 10 MG
RxNorm normalized name: empagliflozin 10 MG
DrugBank: Empagliflozin (DB09038)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 10mg Empagliflozin daily for 12 weeks
Trial: NCT04268277
Drug: Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 100 mg concentrate for solution for infusion
Trial: NCT04268277
Drug: Pembrolizumab
RxNorm normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 100 mg/ 4mL concentrate for solution for infusion
Trial: NCT05833724
Drug: Chidamide
RxNorm normalized name: Chidamide
DrugBank: Tucidinostat (DB06334)
FDA approved: no
EMA approved: no
PMDA approved: yes
Description: Subjects will receive a single dose of 30 mg chidamide. Twice a week.
Trial: NCT05588843
Drug: SAR443122
RxNorm normalized name: SAR443122
DrugBank: SAR443122 (DB16492)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral capsule
Trial: NCT05305547
Drug: S-217622
RxNorm normalized name: TPG-S
DrugBank: Tocofersolan (DB11635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Administered as a round tablet.
Trial: NCT05732961
Drug: Luspatercept
RxNorm normalized name: Luspatercept
DrugBank: Luspatercept (DB12281)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Participants will be treated with Luspatercept, with a starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (administered on Day 1 of each 21-day treatment cycle)
Trial: NCT06446154
Drug: Fruquintinib
RxNorm normalized name: fruquintinib
DrugBank: Fruquintinib (DB11679)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.
Trial: NCT05169060
Drug: Fish Oil Concentrate, 1000 Mg Oral Capsule
RxNorm normalized name: Fish Oil Concentrate, 1000 mg oral capsule
DrugBank: Fish oil (DB13961)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsules, 2 grams or 4 grams per day.
Trial: NCT06136650
Drug: Opevesostat
RxNorm normalized name: Opevesostat
DrugBank: Opevesostat (DB18818)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT06136650
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered orally
Trial: NCT06136650
Drug: Fludrocortisone acetate
RxNorm normalized name: Fludrocortisone Acetate
DrugBank: Fludrocortisone (DB00687)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT06136650
Drug: Abiraterone acetate
RxNorm normalized name: ABIRATERONE ACETATE
DrugBank: Abiraterone (DB05812)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Administered orally
Trial: NCT06136650
Drug: Prednisone acetate
RxNorm normalized name: Prednisone acetate
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT06136650
Drug: Enzalutamide
RxNorm normalized name: Enzalutamide
DrugBank: Enzalutamide (DB08899)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Administered orally
Trial: NCT04783857
Drug: Progesterone 200 MG Oral Capsule
RxNorm normalized name: Progesterone 200 mg oral capsule
DrugBank: Progesterone (DB00396)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Progesterone, 200mg, once daily, oral tablet/capsule
Trial: NCT05123703
Drug: Ocrelizumab
RxNorm normalized name: Ocrelizumab
DrugBank: Ocrelizumab (DB11988)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Ocrelizumab 300 milligrams (mg) will be administered by IV infusion to participants who weigh \< 35 kilograms (kg) and ocrelizumab 600 mg IV will be administered to participants who weigh ≥ 35 kg on Days 1 and 15 (half the dose, 2 weeks apart) and Q24W thereafter.
Trial: NCT05123703
Drug: Fingolimod
RxNorm normalized name: Fingolimod
DrugBank: Fingolimod (DB08868)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Fingolimod will be administered daily as a capsule per the prescribing information (0.25 mg to participants who weigh ≤ 40 kg and 0.5 mg to participants who weigh \> 40 kg).
Trial: NCT05348577
Drug: capivasertib
RxNorm normalized name: Capivasertib
DrugBank: Capivasertib (DB12218)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 320 mg (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 2 to 5, 9 to 12, and 16 to 19 in each week of a 21-day treatment cycle.~Number of Cycles: until disease progression or unacceptable toxicity develops, death, or if the patient requests to stop the study treatment.
Trial: NCT05348577
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients will receive docetaxel in intravenous infusion, 75 mg/m2 BSA, on Day 1 of the 21-day cycles for up to 6 to 10 cycles, according to standard of care practices.
Trial: NCT05797246
Drug: Bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 10 mg/kg IV every three weeks for 3 cycles and then every 6 weeks for a total treatment course of 11 cycles for approximately 1 year total.
Trial: NCT05071430
Drug: HB-01
RxNorm normalized name: scopolamine hydrobromide 0.01 MG
DrugBank: Scopolamine (DB00747)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
Trial: NCT06008288
Drug: JAB-21822
RxNorm normalized name: JAB-21822
DrugBank: JAB-21822 (DB17478)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
Trial: NCT05237687
Drug: Sirolimus
RxNorm normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patients will be randomly assigned to sirolimus or standard of care
Trial: NCT06084936
Drug: Obinutuzumab
RxNorm normalized name: Obinutuzumab
DrugBank: Obinutuzumab (DB08935)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
Trial: NCT06084936
Drug: Glofitamab
RxNorm normalized name: Glofitamab
DrugBank: Glofitamab (DB16371)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
Trial: NCT06084936
Drug: Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive IV rituximab every 28 days for up to 6 cycles (when in combination with bendamustine), or until disease progression (when in combination with lenalidomide).
Trial: NCT06084936
Drug: Bendamustine
RxNorm normalized name: Bendamustine
DrugBank: Bendamustine (DB06769)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
Trial: NCT06084936
Drug: Lenalidomide
RxNorm normalized name: Lenalidomide
DrugBank: Lenalidomide (DB00480)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
Trial: NCT06084936
Drug: Tocilizumab
RxNorm normalized name: Tocilizumab
DrugBank: Tocilizumab (DB06273)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Trial: NCT04721548
Drug: Minoxidil Topical Foam
RxNorm normalized name: minoxidil Topical Foam
DrugBank: Minoxidil (DB00350)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Apply 1 mL of solution twice a day.
Trial: NCT06463028
Drug: Sapanisertib
RxNorm normalized name: SAPANISERTIB
DrugBank: Sapanisertib (DB11836)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral
Trial: NCT06463028
Drug: Serabelisib
RxNorm normalized name: Serabelisib
DrugBank: Serabelisib (DB14935)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral
Trial: NCT06463028
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Infusion
Trial: NCT06035744
Drug: Pembrolizumab
RxNorm normalized name: Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Humanized IgG4 anti-PD-1 monoclonal antibody
Trial: NCT04810611
Drug: MBG453
RxNorm normalized name: Anti-tim-3 monoclonal antibody mbg453
DrugBank: Sabatolimab (DB16322)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-TIM3 monoclonal antibody
Trial: NCT04810611
Drug: NIS793
RxNorm normalized name: Anti-tgf-beta monoclonal antibody nis793
DrugBank: Nisevokitug (DB17561)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Anti-TGF-β monoclonal antibody
Trial: NCT04810611
Drug: canakinumab
RxNorm normalized name: Canakinumab
DrugBank: Canakinumab (DB06168)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Anti-IL-1β monoclonal antibody
Trial: NCT03816319
Drug: UAE Inhibitor TAK-243
RxNorm normalized name: Fibrinolysis inhibitor
DrugBank: TAK-243 (DB15013)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT05859750
Drug: AK104
RxNorm normalized name: Adalimumab
DrugBank: Adalimumab (DB00051)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: AK104 (6mg/kg) on day 1, IV, Q2W
Trial: NCT05859750
Drug: AK104
RxNorm normalized name: Adalimumab
DrugBank: Adalimumab (DB00051)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: AK104 (10mg/kg) on day 1, IV, Q2W
Trial: NCT05859750
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
Trial: NCT05859750
Drug: Nab-Paclitaxel
RxNorm normalized name: NAB-PACLITAXEL COMPONENT PACLITAXEL
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
Trial: NCT06354387
Drug: Alectinib (Alecensa), Nivolumab (Opdivo)
DrugBank: Nivolumab (DB09035)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Alectinib (Alecensa) in Combination with Nivolumab (Opdivo)
Trial: NCT01297400
Drug: Silvadene® Cream 1% [Silver Sulfadiazine]
DrugBank: Sulfadiazine (DB00359)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Topical application, twice a day
Trial: NCT05757219
Drug: Itacitinib
RxNorm normalized name: itacitinib
DrugBank: Itacitinib (DB12154)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants start itacitinib 200 mg PO once daily within 1-4 days after apheresis while awaiting CAR-T-cell manufacturing, which is expected to take approximately from week -4 until day -7. Patients will remain on itacitinib 200 mg PO once daily from initiation until 30 days post-CAR-T-cell therapy (Day 30) including throughout lymphodepleting chemotherapy period (Days -5, -4, -3) and axi-cel infusion (Day 0) for a total of approximately 58 doses.
Trial: NCT05529992
Drug: Velaglucerase Alfa
RxNorm normalized name: Velaglucerase alfa
DrugBank: Velaglucerase alfa (DB06720)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: VPRIV intravenous infusion every other week for 60 minutes.
Trial: NCT06477419
Drug: Sacituzumab govitecan-hziy
RxNorm normalized name: sacituzumab govitecan-hziy
DrugBank: Sacituzumab govitecan (DB12893)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: After enrollment, participants will receive SG until disease progression or intolerable toxicity.
Trial: NCT06127810
Drug: Gadopiclenol
RxNorm normalized name: Gadopiclenol
DrugBank: Gadopiclenol (DB17084)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive Gadopiclenol instead of standard of care contrast
Trial: NCT06344156
Drug: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
RxNorm normalized name: Anti-PD1 / CTLA4 Bispecific Antibody XmAb20717
DrugBank: Vudalimab (DB18833)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines
Trial: NCT05650736
Drug: Abrocitinib 200 mg
RxNorm normalized name: abrocitinib 200 MG
DrugBank: Abrocitinib (DB14973)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Abrocitinib (Cibinqo) is FDA approved at 200 mg dose once daily for the treatment of atopic dermatitis. It is not currently FDA approved for the treatment of GA.
Trial: NCT05501288
Drug: compound pholcodine oral solution
RxNorm normalized name: pholcodine Oral Solution
DrugBank: Pholcodine (DB09209)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients were given compound pholcodine oral solution (Bright Future Pharmaceuticals Factory, Hong Kong, CHN) the day after randomization, with a dose of 5 ml for age 3 to 6 years and 10 ml for age 7 to 18 years, three times daily for 5 consecutive days.
Trial: NCT06168812
Drug: Glipizide
RxNorm normalized name: Glipizide
DrugBank: Glipizide (DB01067)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The therapeutic intervention in this study involves the sulfonylurea glipizide in ER formulation.
Trial: NCT05042973
Drug: Empagliflozin 10 MG
RxNorm normalized name: empagliflozin 10 MG
DrugBank: Empagliflozin (DB09038)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
Trial: NCT06519097
Drug: Vitamin E Delta Tocotrienol
RxNorm normalized name: tocotrienols / vitamin E
DrugBank: Vitamin E (DB00163)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tocotrienols are natural vitamin E compounds that are known to have a neuroprotective effect at nanomolar concentration and anti-carcinogenic effect at micromolar concentration.~400 mg orally, twice daily
Trial: NCT05611931
Drug: Selinexor
RxNorm normalized name: Selinexor
DrugBank: Selinexor (DB11942)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Trial: NCT05522569
Drug: Allogeneic human mesenchymal stem cells (Allo-hMSCs)
RxNorm normalized name: Allogeneic human mesenchymal stem cell
DrugBank: Remestemcel-L (DB13973)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants will be treated with one intravenous (IV) infusion of 200 million allogeneic human mesenchymal stem cells (Allo-hMSCs), lasting from 40-90 minutes following an acute ischemic stroke within 9 days after stroke symptom onset.
Trial: NCT04833114
Drug: Polatuzumab Vedotin
RxNorm normalized name: polatuzumab vedotin
DrugBank: Polatuzumab vedotin (DB12240)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Polatuzumab vedotin 1.8 mg/kg will be administered intravenously on Day 1 of each 21-day cycle for up to 3 cycles.
Trial: NCT04833114
Drug: Mabthera
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Rituximab (Mabthera/Rituxan®) will be administered as per local practice at a dose of 375 mg/m2 intravenously on Day 1 of each 21-day cycle for up to 3 cycles.
Trial: NCT04833114
Drug: Ifosfamide
RxNorm normalized name: Ifosfamide
DrugBank: Ifosfamide (DB01181)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ifosfamide 5000 mg/m² will be administered i.v. over a 24 hr period starting on cycle Day 2.
Trial: NCT04833114
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Carboplatin AUC 5 max 800 mg will be administered i.v. on cycle Day 2.
Trial: NCT04833114
Drug: Etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Etoposide 100 mg/m² will be administered i.v. on cycle Days 1, 2 and 3.
Trial: NCT05747534
Drug: Larazotide Acetate
RxNorm normalized name: Larazotide
DrugBank: Larazotide (DB05645)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: AT1001 (Larazotide) is a locally acting, non-systemic, octapeptide inhibitor of the zonulin receptor that has shown efficacy in a large variety of animal models of inflammation. The effectiveness of AT1001 in controlling paracellular permeability as a tight junction regulator has been widely demonstrated in animal models both in vitro and in vivo. In MIS-C, prolonged presence of SARS-CoV-2 in the GI tract leads to release of zonulin, a biomarker of intestinal permeability, with subsequent trafficking of SARS-CoV-2 antigens into the bloodstream, leading to hyperinflammation (Yonker, et. al. 2021). Five children treated with AT1001 (through an Emergency Investigational New Drug request authorized by the FDA) displayed a decrease in plasma SARS-CoV-2 Spike antigen levels, inflammatory markers, and symptom improvement superior to that achieved with the current standard of treatment for MIS-C (ie. immunoglobulin, systemic steroids) (Yonker, et. al. 2021) (Yonker, et. al. 2022)
Trial: NCT06364904
Drug: Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Chemoimmunotherapy:~1. Tislelizumab: 200mg, 1x time at d1 each cycle~2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle~3. Cisplatin: 70 mg/m2, in d2 each cycle~4. Trilaciclib: 240mg/m2, d1, d2, d8 each cycle~Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W.
Trial: NCT06364904
Drug: Tislelizumab, Cisplatin, Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Chemoimmunotherapy:~1. Tislelizumab: 200mg, 1x time at d1 each cycle~2. Gemcitabine: 1000mg/ m2, in d1, d8 each cycle~3. Cisplatin: 70 mg/m2, in d2 each cycle~Tislelizumab maintenance therapy: after chemoimmunotherapy, 200mg, q3W.