AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT04492891
Drug: Cyclosporine
RxNorm normalized name: Cyclosporine
DrugBank: Cyclosporine (DB00091)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 2.5 mg/kg PO BID 7 days
Trial: NCT01301222
Drug: Inj. Octreotide
DrugBank: Octreotide (DB00104)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 100 mcg subcutaneously for 5 days
Trial: NCT00132015
Drug: tanespimycin
RxNorm normalized name: Tanespimycin
DrugBank: Tanespimycin (DB05134)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT04074317
Drug: PRAM9
RxNorm normalized name: Pramipexole
DrugBank: Pramipexole (DB00413)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: SC injection
Trial: NCT04074317
Drug: Regular Insulin + Pramlintide
DrugBank: Pramlintide (DB01278)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Separate SC injections
Trial: NCT00403273
Drug: Botulinum toxin A
RxNorm normalized name: Botulinum toxin A
DrugBank: Botulinum toxin type A (DB00083)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
Trial: NCT00983281
Drug: Hextend
RxNorm normalized name: Hextend
DrugBank: Hydroxyethyl Starch (DB09106)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV fluid resuscitation to restore euvolemia after traumatic injury and surgery.
Trial: NCT02110992
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT
Trial: NCT01545817
Drug: Pazopanib followed by everolimus
DrugBank: Everolimus (DB01590)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: All patients received Pazopanib (800 mg once daily orally continuous dosing) until disease progression then second line everolimus (10 mg once daily orally continuous dosing)
Trial: NCT01536639
Drug: biphasic insulin aspart 30
RxNorm normalized name: Insulin Aspart
DrugBank: Insulin aspart (DB01306)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Administered by subcutaneous injection. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any
Trial: NCT01914666
Drug: Duloxetine
RxNorm normalized name: Duloxetine
DrugBank: Duloxetine (DB00476)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Administered orally
Trial: NCT02388737
Drug: Vonoprazan
RxNorm normalized name: vonoprazan
DrugBank: Vonoprazan (DB11739)
FDA approved: no
EMA approved: no
PMDA approved: yes
Description: Vonoprazan tablets
Trial: NCT02388737
Drug: Lansoprazole
RxNorm normalized name: Lansoprazole
DrugBank: Lansoprazole (DB00448)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Lansoprazole capsules or tablets
Trial: NCT02388737
Drug: Vonoprazan Placebo
RxNorm normalized name: vonoprazan
DrugBank: Vonoprazan (DB11739)
FDA approved: no
EMA approved: no
PMDA approved: yes
Description: Vonoprazan placebo-matching tablets
Trial: NCT02388737
Drug: Lansoprazole Placebo
DrugBank: Lansoprazole (DB00448)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Lansoprazole placebo-matching capsules
Trial: NCT00276718
Drug: carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00276718
Drug: etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT04490993
Drug: APL-1202 in combination with Epirubicin
DrugBank: Epirubicin (DB00445)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: * Induction period: APL-1202 is administered for 12 consecutive weeks~* Maintenance period: after 12-week drug free period, APL-1202 is administered for another12 consecutive weeks as maintenance treatment~* Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months
Trial: NCT04490993
Drug: Placebo in combination with Epirubicin
DrugBank: Epirubicin (DB00445)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: * Induction period: placebo is administered for 12 consecutive weeks~* Maintenance period: after 12-week drug free period, placebo is administered for another12 consecutive weeks as maintenance treatment~* Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months
Trial: NCT00065533
Drug: pemetrexed
RxNorm normalized name: Pemetrexed
DrugBank: Pemetrexed (DB00642)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT00888303
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
Trial: NCT00888303
Drug: saline solution
RxNorm normalized name: Unisol 4 Saline Solution
DrugBank: Sodium chloride (DB09153)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
Trial: NCT02159547
Drug: Dexketoprofen
RxNorm normalized name: dexketoprofen
DrugBank: Dexketoprofen (DB09214)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 50 mg intravenous arveles in 50 ml saline in 5 minutes
Trial: NCT00200226
Drug: misoprostol
RxNorm normalized name: Misoprostol
DrugBank: Misoprostol (DB00929)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: misoprostol 400mcg 12 hrs prior to procedure
Trial: NCT00200226
Drug: vitamin B6
RxNorm normalized name: vitamin B6
DrugBank: Pyridoxine (DB00165)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Vitamin B6 50 mg orally 12 hrs prior to procedure
Trial: NCT00943228
Drug: mycophenolate mofetil
RxNorm normalized name: Mycophenolate Mofetil
DrugBank: Mycophenolate mofetil (DB00688)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: High dose 4gms daily
Trial: NCT03961100
Drug: Entrectinib 600 mg (T1)
RxNorm normalized name: entrectinib
DrugBank: Entrectinib (DB11986)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets
Trial: NCT03961100
Drug: Entrectinib 600 mg (T2)
RxNorm normalized name: entrectinib
DrugBank: Entrectinib (DB11986)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets
Trial: NCT03961100
Drug: Entrectinib 200 mg (R)
RxNorm normalized name: entrectinib
DrugBank: Entrectinib (DB11986)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Reference formulation (R): entrectinib hard capsules
Trial: NCT03961100
Drug: Entrectinib 200 mg (T)
RxNorm normalized name: entrectinib
DrugBank: Entrectinib (DB11986)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Test formulation (T): entrectinib HPMC capsules
Trial: NCT00204620
Drug: Bendamustin
RxNorm normalized name: Bendamustine
DrugBank: Bendamustine (DB06769)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03422393
Drug: Venetoclax
RxNorm normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: On cycle 1, day 1, patients will initiate venetoclax. The dose of venetoclax will ramp-up from 20 mg PO daily to 400 mg PO daily over a 5 week period.
Trial: NCT03422393
Drug: Ibrutinib
RxNorm normalized name: Ibrutinib
DrugBank: Ibrutinib (DB09053)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: During the screening period, patients will continue on ibrutinib at their previous tolerated dose, unless required to stop (e.g.: by a preceding clinical trial).~On cycle 1, day 1, the dose of ibrutinib will be assigned based on the dose cohort. Patients in cohort 1 will receive ibrutinib 420 mg PO daily. Patients in cohort 2 will receive ibrutinib 560 mg PO daily. Cohort 3 will be 840 mg PO daily.
Trial: NCT03645668
Drug: Meropenem Injection
RxNorm normalized name: meropenem Injection
DrugBank: Meropenem (DB00760)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Different administration types between two groups
Trial: NCT00004238
Drug: pralatrexate
RxNorm normalized name: Pralatrexate
DrugBank: Pralatrexate (DB06813)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03202862
Drug: Fulvestrant
RxNorm normalized name: Fulvestrant
DrugBank: Fulvestrant (DB00947)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Fulvestrant 500 mg given as two 5 ml intramuscular inections, one in each buttoc, on days 1, 15, 2 and every 2 ( ) days thereafter.
Trial: NCT05235191
Drug: methadone tablets
RxNorm normalized name: methadone Oral Tablet
DrugBank: Methadone (DB00333)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The intervention with the active drug (methadone) will start with the dose of 1 tablet (5 mg) twice a day (every 12 hours) and titrated on subsequent visits up to the maximum dose of 6 tablets a day (totaling 30 mg divided into 2 daily doses to facilitate therapeutic adherence).
Trial: NCT00824863
Drug: ketoconazole 2% foam
RxNorm normalized name: KETOCONAZOLE 2% FOAM,TOP
DrugBank: Ketoconazole (DB01026)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: topical antifungal foam to be applied to the folliculitis BID for 2-4 weeks.
Trial: NCT01550419
Drug: Atorvastatin
RxNorm normalized name: Atorvastatin
DrugBank: Atorvastatin (DB01076)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Patients will receive 40mg atorvastatin(one tablet) over night via enteral feeding tube or per os during they stay in ICU at most thirty days.
Trial: NCT00829322
Drug: Modafinil
RxNorm normalized name: Modafinil
DrugBank: Modafinil (DB00745)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Modafinil 100mg once daily for 14 days, increasing to 200mg once daily for a further 14 days
Trial: NCT00004258
Drug: cilengitide
RxNorm normalized name: Cilengitide
DrugBank: Cilengitide (DB11890)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: dose escalation of cilengitide
Trial: NCT01139281
Drug: Ginkgo Biloba Extract (GBE761)
RxNorm normalized name: Ginkgo biloba extract
DrugBank: Ginkgo biloba (DB01381)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The subjects were randomized and allocated in two groups: Control Group(CG) and Study Group(SG). the study group received GBE761(120mg twice a day) plus cisplatin and was guided to ingest GBE761 just before initial cisplatin dosage. The maximum cumulative cisplatin dosage was 300mg/m². They were followed up for ninety days. Comparisons were made between baseline distortion-product otoacoustic emissions measurements and those DPOAE records after maximum cumulative cisplatin dosage.
Trial: NCT01331616
Drug: Bevacizumab (Avastin)
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Dosage is: 10 mg/kg every 2 weeks as monotherapy or in combination (unlabeled) with irinotecan. Patients will also receive Radiotherapy prior to beginning chemotherapy.
Trial: NCT01901003
Drug: Lorazepam
RxNorm normalized name: Lorazepam
DrugBank: Lorazepam (DB00186)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01901003
Drug: Placebo (microcrystalline celluloses)
RxNorm normalized name: Microcrystalline Cellulose
DrugBank: Microcrystalline cellulose (DB14158)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00197327
Drug: Epidural bupivacaine (0.25% versus 0.0625%)
RxNorm normalized name: bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03817619
Drug: Zepatier whole tablet
RxNorm normalized name: Zepatier
DrugBank: Elbasvir (DB11574)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Single-dose ELB/GZR as a whole tablet in a fasted state.
Trial: NCT03817619
Drug: Zepatier crushed tablet
RxNorm normalized name: Zepatier
DrugBank: Elbasvir (DB11574)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Single-dose crushed ELB/GZR in a fasted state.
Trial: NCT03574571
Drug: Docetaxel 75 mg/m2
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.
Trial: NCT03574571
Drug: Docetaxel 60 mg/m2
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.
Trial: NCT03574571
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 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
Trial: NCT03643562
Drug: Adrabetadex
RxNorm normalized name: ADRABETADEX
DrugBank: Adrabetadex (DB15146)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered via lumbar puncture (LP) and IT infusion
Trial: NCT01417403
Drug: hydroxychloroquine
RxNorm normalized name: Hydroxychloroquine
DrugBank: Hydroxychloroquine (DB01611)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given PO
Trial: NCT01414569
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Singe dose preoperatively in 100 ml saline intravenously
Trial: NCT00110812
Drug: IL-2
RxNorm normalized name: IL-2
DrugBank: Human interleukin-2 (DB14865)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 7.5 MIU injected intramuscularly; one arm uses Proleukin together with HAART of choice (protease inhibitor and at least 2 nucleoside/nucleotide reverse transcriptase inhibitors)
Trial: NCT01015248
Drug: Rituximab and Bendamustine
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2
Trial: NCT02008448
Drug: BT injection
RxNorm normalized name: donanemab-azbt Injection
DrugBank: Biomodulin T (DB16529)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01489969
Drug: Neu-P11
RxNorm normalized name: IMMUNOGLOBULIN G1-KAPPA, ANTI-(HOMO SAPIENS ERBB2 (EPIDERMAL GROWTH FACTOR RECEPTOR 2, RECEPTOR TYROSINEPROTEIN KINASE ERBB-2, EGFR2, HER2, HER-2, P185C-ERBB2, NEU, CD340)), HUMANIZED MONOCLONAL ANTIBODY, BIPARATOPIC (TARGETING TWO DIFFERENT NON-OVERLAPP
DrugBank: Zanidatamab (DB15471)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Trial: NCT04476030
Drug: SAGE-217
RxNorm normalized name: SAGE
DrugBank: Sage (DB10982)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsules
Trial: NCT04476030
Drug: Sertraline
RxNorm normalized name: Sertraline
DrugBank: Sertraline (DB01104)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral tablets
Trial: NCT04476030
Drug: Escitalopram
RxNorm normalized name: Escitalopram
DrugBank: Escitalopram (DB01175)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral tablets
Trial: NCT04476030
Drug: Citalopram
RxNorm normalized name: Citalopram
DrugBank: Citalopram (DB00215)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral tablets
Trial: NCT04476030
Drug: Duloxetine
RxNorm normalized name: Duloxetine
DrugBank: Duloxetine (DB00476)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral capsules
Trial: NCT00231101
Drug: Quetiapine
RxNorm normalized name: Quetiapine
DrugBank: Quetiapine (DB01224)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02170584
Drug: BIBR 1048 MS tablet
RxNorm normalized name: morphine
DrugBank: Morphine (DB00295)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02170584
Drug: BIBR 1048 MS oral solution
RxNorm normalized name: morphine
DrugBank: Morphine (DB00295)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00640510
Drug: Rapid Acting Intramuscular Olanzapine
RxNorm normalized name: olanzapine
DrugBank: Olanzapine (DB00334)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 10mg/injection, IM. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
Trial: NCT04567316
Drug: BI 1358894
RxNorm normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Part 2
Trial: NCT00640510
Drug: Isotonic sodium chloride solution
RxNorm normalized name: ISOTONIC SODIUM CHLORIDE SOLUTION
DrugBank: Sodium chloride (DB09153)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 0.9% sodium chloride (NaCl) solution. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
Trial: NCT01462669
Drug: 50mg Ezogabine/retigabine
DrugBank: Ezogabine (DB04953)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
Trial: NCT01462669
Drug: 100mg Ezogabine/retigabine
DrugBank: Ezogabine (DB04953)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
Trial: NCT01462669
Drug: 200mg Ezogabine/retigabine
DrugBank: Ezogabine (DB04953)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
Trial: NCT01462669
Drug: 400mg Ezogabine/retigabine
DrugBank: Ezogabine (DB04953)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
Trial: NCT02163291
Drug: paclitaxel liposome
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: S-1 40 mg/m2 bid d1-14 po and paclitaxel liposome 175mg/m2 d1 intravenously infusion for 3 hours, every 3 weeks. After 2 cycles' treatment, if clinical response is complete response（CR）,partial regression（PR） or stable disease（SD）, another 2 cycles is administered and operation is performed after the total 4 cycles. If response is progressive disease（PD）, chemotherapy is stopped and operation is performed.
Trial: NCT00895739
Drug: cyclosporine
RxNorm normalized name: Cyclosporine
DrugBank: Cyclosporine (DB00091)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00934544
Drug: Ruxolitinib
RxNorm normalized name: Ruxolitinib
DrugBank: Ruxolitinib (DB08877)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 5 mg tablets packaged as 60-count in high-density polyethylene bottles
Trial: NCT04070833
Drug: Fish oil
RxNorm normalized name: Fish oil
DrugBank: Fish oil (DB13961)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Trial: NCT04070833
Drug: Fish oil placebo
DrugBank: Fish oil (DB13961)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Fish oil placebo
Trial: NCT01586468
Drug: WF10
RxNorm normalized name: Sodium hypochlorite
DrugBank: Sodium citrate (DB09154)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 0.5 mg/kg B.W.
Trial: NCT01586468
Drug: NaCl Solution
RxNorm normalized name: sodium chloride
DrugBank: Linaclotide (DB08890)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: NaCl Solution
Trial: NCT04248569
Drug: DNAJB1-PRKACA peptide vaccine
RxNorm normalized name: PEPTIDE-T
DrugBank: Peptide-T (DB19279)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1. DNAJB1-PRKACA peptide vaccine: Day 1, 8, 15 of cycle 1 and Day 1 of cycle 2, 3, 4 and 5 (priming phase). Boost vaccinations: every 3 cycles beginning C6D1. For Cohort A-(Initial) only: Patients with FLC cancer with no prior checkpoint inhibitor therapy treatment.~2. DNAJB1-PRKACA peptide vaccine: Day 1, 8, 15 of cycle 1 and on Day 1 of cycle 2, 3 and 4 (priming phase). Boost vaccinations: every 3 cycles beginning C5D1.~   * Cohort A-(Expansion): Patients with FLC cancer with no prior checkpoint inhibitor treatment.~  * Cohort B: Patients with FLC cancer with prior checkpoint inhibitor treatment.~  * Cohort C: Patients with non-FLC cancer (solid tumors) with prior checkpoint inhibitor treatment eligible.~3. Drug: 0.3 mg DNAJB1-PRKACA peptide vaccine + 0.5mg Poly-ICLC
Trial: NCT04248569
Drug: Nivolumab
RxNorm normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 1. Cohort A (Initial): Nivolumab 3mg/kg will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycle 2-5 during the priming phase. Boost/maintenance vaccinations will be administered as a flat dose of 480mg every 4 weeks starting on Day 1 of Cycle 6.~2. Cohort A (Expansion), B and C: Nivolumab 3mg/kg will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycle 1-4 during the priming phase. Boost/maintenance vaccinations will be administered as a flat dose of 480mg every 4 weeks starting on Day 1 of Cycle 5.~3. Drug: 3mg/kg and 480mg IV
Trial: NCT04248569
Drug: Ipilimumab
RxNorm normalized name: Ipilimumab
DrugBank: Ipilimumab (DB06186)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 1. Cohort A (Initial): Ipilimumab (1 mg/kg) will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycles 2, 3, 4 and 5 of the study, every 3 weeks of the priming phase.~2. Cohort A (Expansion), B and C: Ipilimumab (1 mg/kg) will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycles 1, 2, 3 and 4 of the study, every 3 weeks of the priming phase.~3. Drug: 1mg/kg IV
Trial: NCT01660711
Drug: Irinotecan
RxNorm normalized name: Irinotecan
DrugBank: Irinotecan (DB00762)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)
Trial: NCT01660711
Drug: Oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 85 mg/m² IV infusion on Day 1 over 2 hours
Trial: NCT01436279
Drug: Mifepristone
RxNorm normalized name: Mifepristone
DrugBank: Mifepristone (DB00834)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 200 mg po 20-24 hours prior to the procedure