AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02140333
Drug: Erlotinib
RxNorm normalized name: Erlotinib
DrugBank: Erlotinib (DB00530)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 100mg vs. 150mg
Trial: NCT00354081
Drug: vitamin B6 (pyridoxine)
RxNorm normalized name: Vitamin B6 (Pyridoxine)
DrugBank: Pyridoxine (DB00165)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: vitamin B6 40 mg, in a capsule, taken orally once a day
Trial: NCT00861913
Drug: Pazopanib Hydrochloride
RxNorm normalized name: Pazopanib Hydrochloride
DrugBank: Pazopanib (DB06589)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given orally
Trial: NCT00003173
Drug: thiotepa
RxNorm normalized name: Thiotepa
DrugBank: Thiotepa (DB04572)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT04324112
Drug: binimetinib
RxNorm normalized name: binimetinib
DrugBank: Binimetinib (DB11967)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Binimetinib will be given orally at a dose of 45mg BID continuously for 28-day cycles with no resting period between cycles.
Trial: NCT04324112
Drug: Encorafenib
RxNorm normalized name: encorafenib
DrugBank: Encorafenib (DB11718)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Encorafenib will be given orally at a dose of 450mg QD continuously for 28-day cycles with no resting period between cycles.
Trial: NCT01309139
Drug: Tiotropium
RxNorm normalized name: Tiotropium
DrugBank: Tiotropium (DB01409)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Medium dose of oral inhalation
Trial: NCT01309139
Drug: BI 54903
RxNorm normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Medium dose of oral inhalation
Trial: NCT00745173
Drug: Premarin
RxNorm normalized name: Premarin
DrugBank: Conjugated estrogens (DB00286)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT04023630
Drug: Rivaroxaban 15 MG Oral Tablet
RxNorm normalized name: rivaroxaban 15 MG Oral Tablet
DrugBank: Rivaroxaban (DB06228)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: One 15 mg tablet once daily for up to twelve months
Trial: NCT04023630
Drug: Clopidogrel 75 Mg Oral Tablet
RxNorm normalized name: CLOPIDOGREL 75 mg ORAL TABLET
DrugBank: Clopidogrel (DB00758)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: One 75 mg tablet once daily for up to twelve months
Trial: NCT04023630
Drug: Ticagrelor 90 MG Oral Tablet
RxNorm normalized name: TICAGRELOR 90 mg ORAL TABLET
DrugBank: Ticagrelor (DB08816)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: One 90 mg tablet twice daily for up to twelve months
Trial: NCT03945344
Drug: Tiotropium
RxNorm normalized name: Tiotropium
DrugBank: Tiotropium (DB01409)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral capsule 20 μg
Trial: NCT03058939
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Administered to all patients for a minimum of 8 doses with a possible maximum of 16 doses.
Trial: NCT02872571
Drug: Intramuscular Islet Autograft
RxNorm normalized name: N-[(3E)-1-oxo-3-hexenyl]Somatoliberin (human pancreatic islet)
DrugBank: Tesamorelin (DB08869)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intramuscular Islet Autograft After Extensive Pancreatectomy
Trial: NCT03058939
Drug: Perjeta
RxNorm normalized name: Perjeta
DrugBank: Pertuzumab (DB06366)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Only administered to patients with HER2-positive disease.
Trial: NCT03058939
Drug: Herceptin SC
RxNorm normalized name: Herceptin
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Only administered to patients with HER2-positive disease.
Trial: NCT03058939
Drug: Tamoxifen
RxNorm normalized name: Tamoxifen
DrugBank: Tamoxifen (DB00675)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
Trial: NCT03058939
Drug: Letrozole
RxNorm normalized name: Letrozole
DrugBank: Letrozole (DB01006)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
Trial: NCT03058939
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Only administered to patients who receive paclitaxel and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).
Trial: NCT00636883
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: GEMOX-Erlotinib consists of erlotinib 100 mg orally daily starting day 1, Gemcitabine 1000 mg/m2 in 10 mg/m2/min (100 minutes) infusion on day 1 followed on day 2 by oxaliplatin 100 mg/m2 in a 2-hour infusion. Treatment will be repeated every 2 weeks. Each two weeks is a cycle.If at end of 12 cycles response continues, will administer Gemox and erlotinib till achieve maximum response. Then start Erlotinib maintenance therapy.
Trial: NCT01165580
Drug: valganciclovir [Valcyte]
DrugBank: Ganciclovir (DB01004)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: oral dose, Days 1 and 2
Trial: NCT01863810
Drug: Lyrica
RxNorm normalized name: Lyrica
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.
Trial: NCT01863810
Drug: Lyrica (low dose)
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.
Trial: NCT03793140
Drug: CPI-613
RxNorm normalized name: CPI-1205
DrugBank: CPI-1205 (DB14581)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: CPI-613 \[2,500 mg/m2/day IV\] over 2 hours (+/- 10 mins) Induction tx: Cycle 1 and 2: Treatment on Days 1-5 (Each cycle is 14 days). (Each Cycle is 14 days) Maintenance tx: All subsequent Cycles: Treatment with CPI-613 \[2,500 mg/m2/day IV\] over 2 hours (+/- 10 mins) on Days 1-5 (Each Cycle is 21 days)
Trial: NCT02732587
Drug: Saracatinib
RxNorm normalized name: Saracatinib
DrugBank: Saracatinib (DB11805)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session
Trial: NCT03198637
Drug: Cisatracurium's monitoring by TOF (train-of-four) WATCH device.
DrugBank: Cisatracurium (DB00565)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.
Trial: NCT02257632
Drug: Ranibizumab 0.5 mg
RxNorm normalized name: ranibizumab 0.5 MG in 0.05 ML Injection
DrugBank: Ranibizumab (DB01270)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Administered as an intravitreal injection
Trial: NCT02257632
Drug: Aflibercept 2 mg
RxNorm normalized name: aflibercept 2 MG in 0.05 ML Injection
DrugBank: Aflibercept (DB08885)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Administered as an intravitreal injection
Trial: NCT02707809
Drug: Dexmedetomidine
RxNorm normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dexmedetomidine infusion
Trial: NCT02186366
Drug: Buspirone
RxNorm normalized name: Buspirone
DrugBank: Buspirone (DB00490)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Buspirone by mouth 5mg three times per day for 6week. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.
Trial: NCT03606395
Drug: NV-5138
RxNorm normalized name: NV-5138
DrugBank: NV-5138 (DB19180)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: single ascending dose
Trial: NCT00740727
Drug: Human recombinant hyaluronidase (HRH)
DrugBank: Hyaluronidase (ovine) (DB00070)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)
Trial: NCT03015519
Drug: Albiglutide
RxNorm normalized name: Albiglutide
DrugBank: Albiglutide (DB09043)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 30 mg of lyophilized albiglutide will be delivered from a prefilled dual chamber glass cartridge (DCC). The pen injector system will deliver 0.5 mL albiglutide as a single subcutaneous injection once a week.
Trial: NCT00908011
Drug: Ezetimibe
RxNorm normalized name: Ezetimibe
DrugBank: Ezetimibe (DB00973)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks
Trial: NCT00800748
Drug: Peginterferon alfa-2a
RxNorm normalized name: Peginterferon Alfa-2A
DrugBank: Peginterferon alfa-2a (DB00008)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
Trial: NCT00800748
Drug: Ribavirin
RxNorm normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
Trial: NCT06072248
Drug: Meropenem
RxNorm normalized name: Meropenem
DrugBank: Meropenem (DB00760)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: all patients in both groups receive meropenam and put on the ventilators for 2 weeks
Trial: NCT00285467
Drug: doxercalciferol
RxNorm normalized name: Doxercalciferol
DrugBank: Doxercalciferol (DB06410)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: form of vitamin D that is already in active form.
Trial: NCT00285467
Drug: Cholecalciferol
RxNorm normalized name: Cholecalciferol
DrugBank: Cholecalciferol (DB00169)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: from of vitamin D that requires cells in the body to make active
Trial: NCT03676335
Drug: CsA eye gel
RxNorm normalized name: CsA
DrugBank: Cyclosporine (DB00091)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
Trial: NCT03676335
Drug: CsA for eye emulsion
RxNorm normalized name: CsA
DrugBank: Cyclosporine (DB00091)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The CsA for eye emulsion of 0.4 ml: 0.2 mg
Trial: NCT03676335
Drug: Hypromellose Eye Drops
DrugBank: Hypromellose (DB11075)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Hypromellose Eye Drops of 15ml：75mg, 3 times daily, 1-2 drop
Trial: NCT00072176
Drug: temsirolimus
RxNorm normalized name: Temsirolimus
DrugBank: Temsirolimus (DB06287)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given IV
Trial: NCT01724476
Drug: folate with B12
RxNorm normalized name: vitamin B12
DrugBank: Cyanocobalamin (DB00115)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00628394
Drug: Atomoxetine
RxNorm normalized name: Atomoxetine
DrugBank: Atomoxetine (DB00289)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 40mg 2po qam
Trial: NCT03724175
Drug: ursodiol (ursodeoxycholic acid, UDCA)
RxNorm normalized name: ursodeoxycholate
DrugBank: Ursodeoxycholic acid (DB01586)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: ursodiol (ursodeoxycholic acid, UDCA) 300 mg two times daily for 10 weeks for UC pouchitis patients
Trial: NCT01785875
Drug: Etelcalcetide
RxNorm normalized name: Etelcalcetide
DrugBank: Etelcalcetide (DB12865)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).
Trial: NCT03899337
Drug: Acalabrutinib
RxNorm normalized name: Acalabrutinib
DrugBank: Acalabrutinib (DB11703)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 100mg capsule, PO, BD
Trial: NCT03899337
Drug: Vincristine
RxNorm normalized name: Vincristine
DrugBank: Vincristine (DB00541)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1.4mg/m\^2, IV infusion
Trial: NCT03899337
Drug: Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 375mg/m\^2, IV infusion
Trial: NCT03035409
Drug: Anamorelin Hydrochloride
RxNorm normalized name: Chlorpromazine Hydrochloride
DrugBank: Anamorelin (DB06645)
FDA approved: no
EMA approved: no
PMDA approved: yes
Description: Given PO
Trial: NCT02468661
Drug: erlotinib
RxNorm normalized name: Erlotinib
DrugBank: Erlotinib (DB00530)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03100253
Drug: Tocilizumab
RxNorm normalized name: Tocilizumab
DrugBank: Tocilizumab (DB06273)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 8 mg/kg i.v. every 4 weeks OR 162 mg s.c every seven days
Trial: NCT03100253
Drug: Etanercept
RxNorm normalized name: Etanercept
DrugBank: Etanercept (DB00005)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: a. Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab
Trial: NCT03100253
Drug: Infliximab
RxNorm normalized name: Infliximab
DrugBank: Infliximab (DB00065)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: infliximab if initial failure to the receptor fusion protein, etanercept.
Trial: NCT03100253
Drug: Adalimumab
RxNorm normalized name: Adalimumab
DrugBank: Adalimumab (DB00051)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: adalimumab if initial failure to the receptor fusion protein, etanercept.
Trial: NCT03100253
Drug: Golimumab
RxNorm normalized name: Golimumab
DrugBank: Golimumab (DB06674)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: golimumab if initial failure to the receptor fusion protein, etanercept.
Trial: NCT03100253
Drug: Certolizumab Pegol
RxNorm normalized name: Certolizumab Pegol
DrugBank: Certolizumab pegol (DB08904)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Certolizumab Pegol if initial failure to the receptor fusion protein, etanercept.
Trial: NCT04451226
Drug: Fezolinetant
RxNorm normalized name: Fezolinetant
DrugBank: Fezolinetant (DB15669)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral
Trial: NCT03137082
Drug: Guanfacine XR 3mgs/daily
DrugBank: Guanfacine (DB01018)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Guanfacine 3mg tablet
Trial: NCT00206466
Drug: Taxotere
RxNorm normalized name: Taxotere
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Docetaxel (Taxotere) 100 mg/m2 is to be administered on day 1. A core biopsy is to be performed one day after chemotherapy (day 2) and on days 8, 15 and 22. On day 22, after repeat core biopsy, a second cycle of docetaxel (Taxotere) chemotherapy (100 mg/m2) will be given. Docetaxel (Taxotere) will be given three-weekly for a total of four cycles. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.
Trial: NCT01281696
Drug: Bevacizumab, etoposide, cisplatin
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Bevacizumab (15mg/kg) on D1, etoposide (70mg/m2) on D2-D4, cisplatin (70mg/m2) on D2; 21 days a cycle, for a maximum of 6 cycles
Trial: NCT00707174
Drug: Imiquimod Cream
RxNorm normalized name: Imiquimod Cream
DrugBank: Imiquimod (DB00724)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Our current standard-of-care is to use imiquimod daily for 12 weeks followed by a staged-excision with 2mm margins per stage. These margins are justified because the standard-of care for lentigo maligna is continuing to evolve
Trial: NCT00707174
Drug: Tazarotene Cream 0.1%
DrugBank: Tazarotene (DB00799)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tazarotene is a topical retinoid cream that is commonly used to treat psoriasis and acne. It is known to help keratinocyte maturation and thinning of the stratum corneum (top layer of the epidermis). The stratum corneum functions as the primary barrier to the penetration of topical medications. The penetration of topical medications can be enhanced if the stratum corneum is thinned. We believe that the treatment of lentigo maligna with imiquimod, and staged-excision, will be improved by the addition of tazarotene cream.
Trial: NCT00489931
Drug: VRC-AVIDNA036-00-VP
RxNorm normalized name: VP-14637
DrugBank: VP-14637 (DB12195)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01398592
Drug: Vildagliptin
RxNorm normalized name: Vildagliptin
DrugBank: Vildagliptin (DB04876)
FDA approved: no
EMA approved: yes
PMDA approved: no
Description: 50mg vildagliptin bid
Trial: NCT04061473
Drug: Sitagliptin 100mg
RxNorm normalized name: Sitagliptin 100mg Oral tablet
DrugBank: Sitagliptin (DB01261)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 2 tablets of sitagliptin 100 mg.~Standardized liquid meal Standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g \[U-13C6\]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol.
Trial: NCT04061473
Drug: Empagliflozin 25 MG
RxNorm normalized name: empagliflozin 25 MG
DrugBank: Empagliflozin (DB09038)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 2 tablets of empagliflozin 25 mg.
Trial: NCT01398592
Drug: Sitagliptin
RxNorm normalized name: Sitagliptin
DrugBank: Sitagliptin (DB01261)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 100mg sitagliptin po qd
Trial: NCT01375426
Drug: Oral amoxicillin
RxNorm normalized name: amoxicillin Oral Suspension
DrugBank: Amoxicillin (DB01060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02898116
Drug: Ensartinib
RxNorm normalized name: Ensartinib
DrugBank: Ensartinib (DB14860)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ensartinib was administered orally once daily at a dose of 200 mg during the Run-in Period. During combination therapy, the ensartinib starting dose was to be 200 mg. Based on observed toxicity at the starting dose level, the ensartinib dose may have been escalated to the recommended single-agent dose (225 mg) or de-escalated to the minimum effective dose (150 mg).
Trial: NCT02898116
Drug: Durvalumab
RxNorm normalized name: Durvalumab
DrugBank: Durvalumab (DB11714)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: During combination therapy, durvalumab was to be administered as an IV infusion over 60 (± 5) minutes every 4 weeks at a dose of 1500 mg.
Trial: NCT00765024
Drug: Ivermectin
RxNorm normalized name: Ivermectin
DrugBank: Ivermectin (DB00602)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: single dose of 200 mcg/kg
Trial: NCT00765024
Drug: ivermectin
RxNorm normalized name: Ivermectin
DrugBank: Ivermectin (DB00602)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: two single dose of 200mcg/kg in 2 weeks
Trial: NCT00765024
Drug: Albendazole
RxNorm normalized name: Albendazole
DrugBank: Albendazole (DB00518)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Albendazole 7 days
Trial: NCT03953781
Drug: Effect of levetiracetam on epileptic males reproductive function
RxNorm normalized name: Levetiracetam
DrugBank: Levetiracetam (DB01202)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT00597584
Drug: peginesatide
RxNorm normalized name: Peginesatide
DrugBank: Peginesatide (DB08894)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Trial: NCT02780609
Drug: Selinexor
RxNorm normalized name: Selinexor
DrugBank: Selinexor (DB11942)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
Trial: NCT02780609
Drug: Melphalan
RxNorm normalized name: Melphalan
DrugBank: Melphalan (DB01042)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Trial: NCT02780609
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Trial: NCT02780609
Drug: Fosaprepitant
RxNorm normalized name: Fosaprepitant
DrugBank: Fosaprepitant (DB06717)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Fosaprepitant at 150 mg IV on days -3 and -2.
Trial: NCT02301988
Drug: Ipatasertib
RxNorm normalized name: Ipatasertib
DrugBank: Ipatasertib (DB11743)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
Trial: NCT02301988
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m\^2) as IV infusion QW for 3 cycles.
Trial: NCT02567552
Drug: Subcutaneous progesterone
RxNorm normalized name: Progesterone
DrugBank: Progesterone (DB00396)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: subcutaneous progesterone 25 mg/day
Trial: NCT02567552
Drug: Intramuscular progesterone
RxNorm normalized name: Progesterone
DrugBank: Progesterone (DB00396)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: intramuscular progesterone 50 mg/day