AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT05511831
Drug: Ketotifen Fumarate
RxNorm normalized name: Ketotifen Fumarate
DrugBank: Ketotifen (DB00920)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ketotifen treatment for 3 months, 1 mg each time, 1-2 times a day according to the patient's tolerance
Trial: NCT06236022
Drug: Sirolimus
RxNorm normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: at a dose of 2 mg once daily
Trial: NCT04091074
Drug: Ticagrelor
RxNorm normalized name: Ticagrelor
DrugBank: Ticagrelor (DB08816)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Half of patients undergoing carotid stenting take ticagrelor+aspirin
Trial: NCT04091074
Drug: Clopidogrel
RxNorm normalized name: Clopidogrel
DrugBank: Clopidogrel (DB00758)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin
Trial: NCT05997017
Drug: nab-sirolimus
RxNorm normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Prospective Phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients
Trial: NCT00000985
Drug: Vidarabine
RxNorm normalized name: Vidarabine
DrugBank: Vidarabine (DB00194)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00000985
Drug: Acyclovir
RxNorm normalized name: Acyclovir
DrugBank: Acyclovir (DB00787)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00000985
Drug: Foscarnet sodium
RxNorm normalized name: Foscarnet Sodium
DrugBank: Foscarnet (DB00529)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT06378346
Drug: Glycyrrhizin
RxNorm normalized name: Glycyrrhizin
DrugBank: Glycyrrhizic acid (DB13751)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 75mg orally daily
Trial: NCT05602363
Drug: Docirbrutinib
RxNorm normalized name: Rocbrutinib
DrugBank: Rutin (DB01698)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral tablet, twice daily
Trial: NCT04789668
Drug: Bintrafusp Alfa
RxNorm normalized name: Bintrafusp alfa
DrugBank: Bintrafusp alfa (DB15387)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT04789668
Drug: Pimasertib
RxNorm normalized name: Pimasertib
DrugBank: Pimasertib (DB14904)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT05430217
Drug: Buspirone
RxNorm normalized name: Buspirone
DrugBank: Buspirone (DB00490)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 tablet (15 mg) once per day for 28 days
Trial: NCT05332821
Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: PD-1/PD-L1 inhibitors: atezolizumab, sintilimab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, toripalimab, durvalumab, penpulimab, and other ICIs; VEGF-TKI/bevacizumab: sorafenib, lenvatinib, donafenib, apatinib, anlotinib, bevacizumab/ bevacizumab biosimilar, and other anti-angiogenesis drugs; Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs only include marketed drugs but are not limited to HCC approval.
Trial: NCT04743687
Drug: Zanubrutinib
RxNorm normalized name: Zanubrutinib
DrugBank: Zanubrutinib (DB15035)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Oral Zanuburutinib, 160mg twice a day
Trial: NCT06275204
Drug: Bismuth-based quadruple therapy
RxNorm normalized name: bismuth
DrugBank: Bismuth cation (DB14572)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants who are positive with H. pylori will receive bismuth-based quadruple therapy:~Antibiotic 1 - Amoxicillin 4 x 500 mg or Clarithromycin 2 x 400 mg, Antibiotic 2 - Metronidazole 4 x 400 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg, Colloidal bismuth - Bismuth oxide 4 x 120 mg.
Trial: NCT06275204
Drug: Levofloxacin-based quadruple therapy
RxNorm normalized name: Levofloxacin
DrugBank: Levofloxacin (DB01137)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: In case there will be a treatment failure after Protocol I is completed, the remaining patients with a positive infection will be referred to a secondary treatment:~Antibiotic 1 - Levofloxacin 1 x 500 mg, Antibiotic 2 - Metronidazole 4 x 400 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg, Colloidal bismuth - Bismuth oxide 4 x 120 mg.
Trial: NCT06275204
Drug: Levofloxacin-based triple
RxNorm normalized name: Levofloxacin
DrugBank: Levofloxacin (DB01137)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants with treatment failure will be recommended second line treatment - levofloxacin-based:~Antibiotic 1 - Levofloxacin 2 x 500 mg, Antibiotic 2 - Amoxicillin 2 x 1000 mg, Proton pump inhibitor - Esomeprazole 2 x 40 mg
Trial: NCT06530823
Drug: Pemigatinib and Durvalumab
DrugBank: Durvalumab (DB11714)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Pemigatinib combined with Durvalumab Pemigatinib: 13.5mg, oral administration, once daily, swallow the entire tablet with or without food. Take for 2 weeks and then discontinue for 1 week. Durvalumab: 1500mg, intravenous infusion, once every three weeks. Each infusion should take over 60 minutes.
Trial: NCT04969731
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: IV
Trial: NCT06725121
Drug: Yttrium-90 (Y-90)
RxNorm normalized name: Zevalin 3.2mg/2mL Kit for the Preparation of Yttrium-90 (Y-90) Solution for Injection
DrugBank: Yttrium Y-90 (DB13076)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Storage, administration and treatment of Y90-RE will be done according to established treatment protocols and standard of care at UHN.
Trial: NCT04780581
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 6 mg/24h - 10 days
Trial: NCT04780581
Drug: Methylprednisolone
RxNorm normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 250 mg/ 24h - 3 days
Trial: NCT06727409
Drug: Finerenone
RxNorm normalized name: Finerenone
DrugBank: Finerenone (DB16165)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Finerenone 10mg or 20 mg as tolerated on top of maximal tolerated RASi and stable SGLT2i therapy
Trial: NCT06706544
Drug: Ozone therapy
RxNorm normalized name: ozone
DrugBank: Ozone (DB12510)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Usual treatment (by their oncologist or hematologist) + Ozone therapy by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
Trial: NCT06706544
Drug: Oxygen (placebo)
DrugBank: Oxygen (DB09140)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Usual treatment (by their oncologist or hematologist) + Oxygen by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
Trial: NCT06704620
Drug: Diphenhydramine
RxNorm normalized name: Diphenhydramine
DrugBank: Diphenhydramine (DB01075)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Diphenhydramine intramuscular injection 20mg qd d0-2 Q3W
Trial: NCT06704620
Drug: Tislelizumab
RxNorm normalized name: Tislelizumab
DrugBank: Tislelizumab (DB14922)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tislelizumab intravenous infusion 200mg d1
Trial: NCT06704620
Drug: Pemetrexed
RxNorm normalized name: Pemetrexed
DrugBank: Pemetrexed (DB00642)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pemetrexed intravenous infusion 500mg/m2 d1
Trial: NCT06704620
Drug: Albumin paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Albumin paclitaxel intravenous infusion 260mg/m2 d1
Trial: NCT06704620
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Carboplatin intravenous infusion AUC5 d1
Trial: NCT06704620
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cisplatin intravenous infusion 75mg/m2 d1
Trial: NCT06706791
Drug: Empagliflozin 10 MG
RxNorm normalized name: empagliflozin 10 MG
DrugBank: Empagliflozin (DB09038)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: participants will be divided in two groups one group will empagliflozin 10mg once daily along with standard treatment secong group receiving placebo once daily along with standard treatment.
Trial: NCT06709196
Drug: Pivmecillinam
RxNorm normalized name: pivmecillinam
DrugBank: Pivmecillinam (DB01605)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Orally administered pivmecillinam 400mg
Trial: NCT06709196
Drug: Pivmecillinam
RxNorm normalized name: pivmecillinam
DrugBank: Pivmecillinam (DB01605)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Amoxicillin clavulanic acid
RxNorm normalized name: amoxicillin / clavulanate
DrugBank: Clavulanic acid (DB00766)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Amoxicillin
RxNorm normalized name: Amoxicillin
DrugBank: Amoxicillin (DB01060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Cefuroxime
RxNorm normalized name: Cefuroxime
DrugBank: Cefuroxime (DB01112)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Ciprofloxacin
RxNorm normalized name: Ciprofloxacin
DrugBank: Ciprofloxacin (DB00537)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Linezolid
RxNorm normalized name: Linezolid
DrugBank: Linezolid (DB00601)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Nitrofurantoin
RxNorm normalized name: Nitrofurantoin
DrugBank: Nitrofurantoin (DB00698)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Trimethoprim
RxNorm normalized name: Trimethoprim
DrugBank: Trimethoprim (DB00440)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Sulfamethoxazole trimethoprim
RxNorm normalized name: sulfamethoxazole / trimethoprim
DrugBank: Trimethoprim (DB00440)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT06709196
Drug: Fluconazole
RxNorm normalized name: Fluconazole
DrugBank: Fluconazole (DB00196)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trial: NCT05916690
Drug: Electrochemotherapy with bleomycin or cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Bleomycin (DB00290)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Combination of drug delivery platform (electroporation) and drug (bleomycin)
Trial: NCT06707389
Drug: Methylprednisolone
RxNorm normalized name: Methylprednisolone
DrugBank: Methylprednisolone (DB00959)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. Intratympanic injection of methylprednisolone was performed three times a week.
Trial: NCT06709495
Drug: PEEL-224
RxNorm normalized name: orange peel
DrugBank: Orange (DB10549)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Topoisomerase 1 inhibitor, 200mg amber vial, via intravenous (into the vein) infusion per protocol.
Trial: NCT06709495
Drug: Temozolomide
RxNorm normalized name: Temozolomide
DrugBank: Temozolomide (DB00853)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Alkylating agent, 5, 20, 100, 140, 180, or 250 mg capsule, taken orally per standard of care.
Trial: NCT06709495
Drug: Vincristine
RxNorm normalized name: Vincristine
DrugBank: Vincristine (DB00541)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Vinca alkaloid, 1 or 2mL vials, via intravenous (into the vein) infusion per institutional policy.
Trial: NCT06713421
Drug: Dimethicone+Pronase
RxNorm normalized name: Dimethicone
DrugBank: Dimethicone (DB11074)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder and 20,000 IU pronase granules combined with 1 g NaHCO3.
Trial: NCT06713421
Drug: Dimethicone
RxNorm normalized name: Dimethicone
DrugBank: Dimethicone (DB11074)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.
Trial: NCT06711705
Drug: Elranatamab
RxNorm normalized name: ELRANATAMAB
DrugBank: Elranatamab (DB15395)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subcutaneous injection of elranatamab. If patient achieves MRD negative remission, patient would enter treatment-free observation period with MRD monitoring.
Trial: NCT06728631
Drug: Candonilimab and ATRA
RxNorm normalized name: ATRA
DrugBank: Tretinoin (DB00755)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Candonilimab at a dose of 6mg/kg IV Q3W will be administered until a maximum treatment duration of 1 year. All-trans retinoic acid will be administered at a dose of 25mg/m² twice daily on days 1-14, with a treatment cycle of 21 days, until a maximum treatment duration of 6 months, or until the occurrence of oral cancer or other malignancies, death, intolerable toxicity, withdrawal of informed consent, or any other reasons specified in the protocol.
Trial: NCT06427226
Drug: Dapagliflozin 10mg Tab
RxNorm normalized name: DAPAGLIFLOZIN 10MG TAB
DrugBank: Dapagliflozin (DB06292)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Dapagliflozin 10 mg tab once daily given during the duration of AC cycles.
Trial: NCT06723717
Drug: Daily infusion of dornase alfa
RxNorm normalized name: Dornase Alfa
DrugBank: Dornase alfa (DB00003)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Daily infusion of dornase alfa at a dose of 125 microg/kg as an intravenous bolus until day 14 after SAH
Trial: NCT06733051
Drug: Golidocitinib
RxNorm normalized name: Golidocitinib
DrugBank: Golidocitinib (DB18057)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 150 mg, administered once daily from Day 1 to Day 21 (D1-D21)
Trial: NCT06733051
Drug: Benmelstobart
RxNorm normalized name: Benmelstobart
DrugBank: APL-502 (DB17473)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1200 mg, administered on Day 1 (D1) of every cycle
Trial: NCT06720610
Drug: Vonoprazan 20 mg
RxNorm normalized name: vonoprazan 20 MG
DrugBank: Vonoprazan (DB11739)
FDA approved: no
EMA approved: no
PMDA approved: yes
Description: Vonoprazan PO, 20mg, once a day, 14 days.
Trial: NCT06720610
Drug: Esomeprazole
RxNorm normalized name: Esomeprazole
DrugBank: Esomeprazole (DB00736)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Esomeprazole PO, 40mg, once a day, 14 days
Trial: NCT06721494
Drug: Methamphetamine
RxNorm normalized name: Methamphetamine
DrugBank: Metamfetamine (DB01577)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Methamphetamine HCl for intravenous administration
Trial: NCT06727864
Drug: 6-month (2HERZ/4HRE)
RxNorm normalized name: leuprolide
DrugBank: Leuprolide (DB00007)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2 months of HREZ followed by 4 months of HR/HRE
Trial: NCT06293677
Drug: Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem
RxNorm normalized name: piperacillin / tazobactam
DrugBank: Piperacillin (DB00319)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Meropenem dosages according to eGFR \[mL/min/1.73 m²\] :~eGFR 120-149 : 40 mg/kg q6 h eGFR 150-199 : 30 mg/kg q4h eGFR 200-299 : 40 mg/kg q4h eGFR \&amp;gt;/= 300 : 40 mg/kg q4h~Piperacillin-tazobatam dosages according to eGFR \[mL/min/1.73 m²\] :~eGFR 120-149 : 150 mg/kg q6 h eGFR 150-199 : 120 mg/kg q4h eGFR 200-299 : 150 mg/kg q4h eGFR \&amp;gt;/= 300 : 180 mg/kg q4h~The maximum doses for the antibiotic prescription before the first drug monitoring will be 2gr of MER every 4 hours and 4gr of PIP every 4 hours.~The duration of infusion will be set to 2 h.
Trial: NCT06293677
Drug: Standard dosages of piperacillin-tazobactam or meropenem
RxNorm normalized name: piperacillin / tazobactam
DrugBank: Piperacillin (DB00319)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Meropenem dosages according to eGFR \[mL/min/1.73 m²\] :~eGFR\> 50 : 40mg/kg q8h eGFR 25-49 : 40mg/kg q12h eGFR 15-24 : 20mg/kg q12h~Piperacillin-tazobactam :~eGFR \>50 : 100mg/kg q6h eGFR 20-49 : 50mg/kg q6h eGFR 15-29 : 50 mg/kg q8h
Trial: NCT04808973
Drug: Dolutegravir plus lamivudine in a FDC
RxNorm normalized name: DOLUTEGRAVIR/LAMIVUDINE
DrugBank: Lamivudine (DB00709)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: All participants will receive an ART regimen composed by Lamivudine plus Dolutegravir in a single pill (FDC)
Trial: NCT06727734
Drug: Levonorgestrel
RxNorm normalized name: Levonorgestrel
DrugBank: Levonorgestrel (DB00367)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Levonorgestrel 1.5 mg
Trial: NCT06727734
Drug: Ulipristal Acetate
RxNorm normalized name: Ulipristal Acetate
DrugBank: Ulipristal (DB08867)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Ulipristal 30 mg
Trial: NCT06296082
Drug: Botulinum toxin type A
RxNorm normalized name: Botulinum toxin type A
DrugBank: Botulinum toxin type A (DB00083)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: Botulinum toxin type A injections are a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a chimical disruption of dysfunctional endplates.
Trial: NCT05142241
Drug: Talazoparib
RxNorm normalized name: TALAZOPARIB
DrugBank: Talazoparib (DB11760)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT05142241
Drug: Temozolomide
RxNorm normalized name: Temozolomide
DrugBank: Temozolomide (DB00853)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given PO
Trial: NCT05355441
Drug: Paracetamol
RxNorm normalized name: Paracetamol
DrugBank: Acetaminophen (DB00316)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Routine clinical practice treatments recommended by the medical team involved
Trial: NCT05355441
Drug: Tramadol
RxNorm normalized name: Tramadol
DrugBank: Tramadol (DB00193)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Routine clinical practice treatments recommended by the medical team involved
Trial: NCT05355441
Drug: Morphine
RxNorm normalized name: Morphine
DrugBank: Morphine (DB00295)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Routine clinical practice treatments recommended by the medical team involved
Trial: NCT06722586
Drug: Sirolimus
RxNorm normalized name: Sirolimus
DrugBank: Sirolimus (DB00877)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Sirolimus two pills (1mg) per day
Trial: NCT06731699
Drug: FD-001
RxNorm normalized name: FD&C Blue #2
DrugBank: Indigotindisulfonic acid (DB11577)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The initial dose was 0.4mg, and subsequent doses of 0.8mg, 1.6mg, 2.4mg, 3.2mg, and 4.0mg were proposed to be administered in a progressive manner using the rapid titration method combined with the traditional 3+3 experimental design. The trial process consists of three periods: screening period, treatment period, and follow-up period. The screening period lasted from D-28 to D-1 for treatment (DLT observation period): during this time frame, there was a single administration period (C0D1-C0D4) where oral administration occurred on day one followed by safety observations on days two to four; as well as multiple administration period one (C1D1-C1D28) where oral administration took place on days one to two and seven to nine with rest periods in between. The drug is available in capsule form.
Trial: NCT06730542
Drug: Zanubrutinib
RxNorm normalized name: Zanubrutinib
DrugBank: Zanubrutinib (DB15035)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Zanubrutinib capsules will be self-administered orally by participants at a starting dose of 160 mg twice a day (BID) or 320 mg once a day (QD)\* at the beginning of Cycle 2 of Pola-R-CHP therapy.
Trial: NCT06730542
Drug: Polatuzumab Vedotin
RxNorm normalized name: polatuzumab vedotin
DrugBank: Polatuzumab vedotin (DB12240)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive Polatuzumab Vedotin as per standard of care (SOC).
Trial: NCT06730542
Drug: Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive Rituximab as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
Trial: NCT06730542
Drug: Prednisone
RxNorm normalized name: Prednisone
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will receive Prednisone as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
Trial: NCT06732258
Drug: Tifcemalimab injection
RxNorm normalized name: Tifcemalimab
DrugBank: Tifcemalimab (DB18914)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100 mg or 200 mg q3w until disease progression or intolerable toxicity;
Trial: NCT06732258
Drug: Toripalimab
RxNorm normalized name: Toripalimab
DrugBank: Toripalimab (DB15043)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 240 mg q3w until disease progression or intolerable toxicity;
Trial: NCT06732258
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 75 mg/m2 q3w for 4-6 cycles;
Trial: NCT06732258
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: AUC = 5, q3w for 4-6 cycles;
Trial: NCT06732258
Drug: Etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 100 mg/m2, d1, d2, d3, q3w for 4-6 cycles;
Trial: NCT06592261
Drug: Octreotide Acetate, 6-45 ng/kg/min
DrugBank: Octreotide (DB00104)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Suppression of endogenous insulin secretion
Trial: NCT06592261
Drug: Dextrose 20 % in Water
RxNorm normalized name: dextrose 20 % in water
DrugBank: Water (DB09145)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Production of steady-state plasma glucose (SSPG) reflective of insulin sensitivity at hyperinsulinemia