TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00793546
Drug: Exemestane
Normalized name: Exemestane
DrugBank: Exemestane (DB00990)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs
Study: NCT01593137
Drug: Liraglutide + metformin
Normalized name: Liraglutide
DrugBank: Metformin (DB00331)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Liraglutide 1.8 mg/day + metformin \>1500mg/day. Liraglutide will be administered once daily by subcutaneous injection, either in the abdomen, thigh or upper arm.~Patients will continue on metformin therapy as they were prescribed before enrolment.
Study: NCT01593137
Drug: Glimepiride + metformin
Normalized name: Glimepiride
DrugBank: Glimepiride (DB00222)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Glimepiride 4 mg/day + metformin \>1500 mg/day. Tablets should be swallowed whole with some liquid before or during a substantial breakfast or, if none is taken, shortly before or during the first main meal.~Patients will continue on metformin therapy as they were prescribed before enrolment.
Study: NCT00484198
Drug: Pioglitazone
Normalized name: Pioglitazone
DrugBank: Pioglitazone (DB01132)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 45 mg over-encapsulated tablet administered orally, once daily
Study: NCT00484198
Drug: Rivoglitazone
Normalized name: Rivoglitazone
DrugBank: Rivoglitazone (DB09200)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1.0 mg tablet administered orally, once daily
Study: NCT00484198
Drug: Rivoglitazone
Normalized name: Rivoglitazone
DrugBank: Rivoglitazone (DB09200)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1.5 mg tablet administered orally, once daily
Study: NCT03090698
Drug: Triamcinolone
Normalized name: Triamcinolone
DrugBank: Triamcinolone (DB00620)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intra-articular administration
Study: NCT04588727
Drug: Ticagrelor
Normalized name: Ticagrelor
DrugBank: Ticagrelor (DB08816)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: In Part B, subjects will receive oral ticagrelor tablets.
Study: NCT03622580
Drug: Aflibercept
Normalized name: Aflibercept
DrugBank: Aflibercept (DB08885)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
Study: NCT03622580
Drug: Faricimab
Normalized name: Faricimab
DrugBank: Faricimab (DB15303)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
Study: NCT04499898
Drug: Carvedilol
Normalized name: Carvedilol
DrugBank: Carvedilol (DB01136)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Carvedilol
Study: NCT00379431
Drug: Administration of rituximab and methylprednisolone
Normalized name: Rituximab
DrugBank: Rituximab (DB00073)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Rituximab:~Pharmaceutical form: Concentrate for solution for infusion. Maximum duration of treatment: 28 weeks Maximum dose allowed: 2000 mg (use of total dose) Route of administration: intravenous use.
Study: NCT00366119
Drug: Ramipril
Normalized name: Ramipril
DrugBank: Ramipril (DB00178)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00435019
Drug: insulin detemir
Normalized name: Insulin Detemir
DrugBank: Insulin detemir (DB01307)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: s.c. injection, once or twice daily.
Study: NCT00435019
Drug: insulin aspart
Normalized name: Insulin Aspart
DrugBank: Insulin aspart (DB01306)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: s.c. injection, at main meals.
Study: NCT03462459
Drug: Vancomycin
Normalized name: Vancomycin
DrugBank: Vancomycin (DB00512)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Vancomycin capsule, 125 mg
Study: NCT00441532
Drug: Lidocaine
Normalized name: Lidocaine
DrugBank: Lidocaine (DB00281)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00403845
Drug: Indacaterol 150 μg
DrugBank: Indacaterol (DB05039)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Study: NCT00403845
Drug: Indacaterol 300 μg
DrugBank: Indacaterol (DB05039)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Study: NCT02535351
Drug: sunitinib or pazopanib
DrugBank: Sunitinib (DB01268)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: First-line treatment
Study: NCT02268747
Drug: Dacomitinib
Normalized name: DACOMITINIB
DrugBank: Dacomitinib (DB11963)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: The patients will assume Dacomitinib 30 mg daily for the first 2 weeks. If the highest skin toxicity will be of grade \<2, then the patients will start dacomitinib at 45 mg once daily and they will be clinically assessed every cycle (i.e. every 28 days).~If the highest skin toxicity will be grade \>2, then the patient will interrupt the treatment following the criteria for dose reduction.
Study: NCT03053427
Drug: Gabapentin enacarbil
Normalized name: Gabapentin Enacarbil
DrugBank: Gabapentin enacarbil (DB08872)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral administration
Study: NCT00865943
Drug: Citalopram HBr eq. 10 mg tablets, single dose
DrugBank: Citalopram (DB00215)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A: Experimental Subjects received Purepac formulated products under fasting conditions
Study: NCT00834730
Drug: N2O gas vs ketamine
DrugBank: Ketamine (DB01221)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
Study: NCT02583438
Drug: Saxagliptin (Bristol-Myers Squibb Company)
Normalized name: Saxagliptin
DrugBank: Saxagliptin (DB06335)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 6-month treatment of Saxagliptin 5mg Qd
Study: NCT04440956
Drug: 64Cu-SARTATE
Normalized name: 64Cu-dotatate
DrugBank: Cu-64 sartate (DB18170)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200MBq of 64Cu-MeCOSar-Octreotate (64Cu-SARTATE) given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.
Study: NCT04470089
Drug: Myramistin
Normalized name: Miramistin ion
DrugBank: Miramistin ion (DB19386)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oromucosal application
Study: NCT02404389
Drug: Active comparator
Normalized name: Activated Charcoal
DrugBank: Activated charcoal (DB09278)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.
Study: NCT00755794
Drug: montelukast sodium
Normalized name: Montelukast Sodium
DrugBank: Montelukast (DB00471)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Montelukast Tablet, 10 mg, 8 weeks, daily
Study: NCT02892318
Drug: Atezolizumab
Normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Atezolizumab 840 mg administered by IV infusion on Days 8 and 22 of each 28-day cycle.
Study: NCT04045093
Drug: Dabigatran etexilate
Normalized name: Dabigatran etexilate
DrugBank: Dabigatran etexilate (DB06695)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran or Warfarin for stroke prevention, in a open-label design.
Study: NCT04045093
Drug: Warfarin
Normalized name: Warfarin
DrugBank: Warfarin (DB00682)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Subjects will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran or Warfarin for stroke prevention, in a open-label design.
Study: NCT00576732
Drug: Risperidone high dose
Normalized name: Risperidone
DrugBank: Risperidone (DB00734)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Risperidone oral solution 1.25 mg (if \<45 kg) or 1.75 mg (if \>=45 kg) qd or bid for 6 weeks
Study: NCT00576732
Drug: Risperidone low dose
Normalized name: Risperidone
DrugBank: Risperidone (DB00734)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Risperidone oral solution 0.125 mg (if \<45 kg) or 0.175 mg (if \>=45 kg) qd or bid for 6 weeks
Study: NCT00578721
Drug: Aspirin
Normalized name: Aspirin
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 325 mg taken daily with an arginine-restricted diet
Study: NCT03219008
Drug: Fluvoxamine
Normalized name: Fluvoxamine
DrugBank: Fluvoxamine (DB00176)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Fluvoxamine could inhibit CYP1A2 and CYP2C19 and affect the metabolism of melatonin, and help to release symptoms of depressive disorder with sleep problems.
Study: NCT03219008
Drug: Lithium+fluvoxamine
DrugBank: Fluvoxamine (DB00176)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: the investigators recommend lithium as a mood stabilizer and use fluvoxamine to affect the level of melatonin.
Study: NCT03219008
Drug: mirtazapine + SNRIs
Normalized name: Mirtazapine
DrugBank: Mirtazapine (DB00370)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: the investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder.
Study: NCT01547299
Drug: Enzalutamide
Normalized name: Enzalutamide
DrugBank: Enzalutamide (DB08899)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01547299
Drug: Leuprolide
Normalized name: Leuprolide
DrugBank: Leuprolide (DB00007)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01547299
Drug: Dutasteride
Normalized name: Dutasteride
DrugBank: Dutasteride (DB01126)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT04305002
Drug: Exenatide
Normalized name: Exenatide
DrugBank: Exenatide (DB01276)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Injections, 2 mg once weekly for 18 months
Study: NCT00800280
Drug: PD 0332334
Normalized name: dolutegravir
DrugBank: Dolutegravir (DB08930)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Single 300 mg dose of PD 0332334 immediate release capsules administered orally
Study: NCT00800280
Drug: PD 0332334
Normalized name: dolutegravir
DrugBank: Dolutegravir (DB08930)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
Study: NCT00800280
Drug: cimetidine
Normalized name: Cimetidine
DrugBank: Cimetidine (DB00501)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.
Study: NCT00001502
Drug: RMP-7 and carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02101359
Drug: T2380
Normalized name: Treprostinil
DrugBank: Treprostinil (DB00374)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 200 microlitres of T2380 will be administrated intracamerally
Study: NCT02101359
Drug: Tetracaine
Normalized name: Tetracaine
DrugBank: Tetracaine (DB09085)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Study: NCT04620954
Drug: Oregovomab
Normalized name: Oregovomab
DrugBank: Oregovomab (DB04964)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 2mg of Oregovomab is administered through IV on Weeks 1, 5, 9, 17.
Study: NCT04620954
Drug: Nivolumab
Normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 480mg of Nivolumab is administered through IV every 4 weeks (Weeks 9, 13, 17, 21).
Study: NCT03070405
Drug: Tenofovir disoproxil fumarate 300mg
Normalized name: TENOFOVIR DISOPROXIL FUMARATE 300MG TAB
DrugBank: Tenofovir disoproxil (DB00300)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Single oral dose on the first day of each period
Study: NCT03070405
Drug: Para-aminosalicylic acid Ca granule 5.28 g
DrugBank: Aminosalicylic acid (DB00233)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Twice daily oral administration from the first day of each period to the seventh dose
Study: NCT02811497
Drug: Azacitidine
Normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT02811497
Drug: Durvalumab
Normalized name: Durvalumab
DrugBank: Durvalumab (DB11714)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT02892318
Drug: Guadecitabine
Normalized name: Guadecitabine
DrugBank: Guadecitabine (DB11918)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Guadecitabine 60 mg/m\^2 SC on Days 1-5 of every 28-day cycle.
Study: NCT00006214
Drug: flutamide
Normalized name: Flutamide
DrugBank: Flutamide (DB00499)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03022825
Drug: N-803 and BCG
Normalized name: Tice BCG
DrugBank: Bacillus calmette-guerin substrain tice live antigen (DB10343)
Approvals — FDA: no, EMA: no, PMDA: no
Description: BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36.
Study: NCT03022825
Drug: N-803
Normalized name: N-803 COMPONENT IL-15R.ALPHA.SU/FC FUSION PROTEIN
DrugBank: Inbakicept (DB16479)
Approvals — FDA: no, EMA: no, PMDA: no
Description: N-803 will be administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36.
Study: NCT04400045
Drug: Treosulfan
Normalized name: TREOSULFAN
DrugBank: Treosulfan (DB11678)
Approvals — FDA: no, EMA: yes, PMDA: no
Description: Treosulfan 21mg/m2 (days -6, -5, -4)
Study: NCT00316862
Drug: cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT00316862
Drug: irinotecan hydrochloride
Normalized name: Irinotecan Hydrochloride
DrugBank: Irinotecan (DB00762)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01396395
Drug: Nicorandil
Normalized name: nicorandil
DrugBank: Nicorandil (DB09220)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The subjects will receive Nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with the standard treatment.
Study: NCT01396395
Drug: Standard Treatment
Normalized name: Azo-Standard
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The subjects will receive one of the standard anti-anginal therapies which included but not limited to aspirin, ACEI, lipid lowering statins and beta blockers according to the recommendation of guidelines. If the subject's condition permitted, they should take all these medicines. However, the dose, route, frequency and duration were determined by investigators according to subject's specific condition.
Study: NCT03682705
Drug: Elsubrutinib
Normalized name: Elsubrutinib
DrugBank: Elsubrutinib (DB18850)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Elsubrutinib capsule will be administered orally.
Study: NCT00874562
Drug: Rapamycin
Normalized name: Rapamycin
DrugBank: Sirolimus (DB00877)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Taken orally mixed with water or orange juice
Study: NCT00207727
Drug: CNTO 1275
Normalized name: Human monoclonal antibody targeting CC-chemokine ligand 2 (CNTO 888)
DrugBank: Carlumab (DB12718)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03682705
Drug: Upadacitinib
Normalized name: Upadacitinib
DrugBank: Upadacitinib (DB15091)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Upadacitinib tablet will be administered orally.
Study: NCT03759366
Drug: Eculizumab
Normalized name: Eculizumab
DrugBank: Eculizumab (DB01257)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Eculizumab will be administered by IV infusion.
Study: NCT00732680
Drug: Botulinum Toxin Type A
Normalized name: Botulinum toxin type A
DrugBank: Botulinum toxin type A (DB00083)
Approvals — FDA: no, EMA: yes, PMDA: yes
Description: 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
Study: NCT03526926
Drug: CPX-351
Normalized name: CPX
DrugBank: DPCPX (DB12946)
Approvals — FDA: no, EMA: no, PMDA: no
Description: VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.
Study: NCT02753075
Drug: Fluoride toothpaste
Normalized name: sodium fluoride Toothpaste
DrugBank: Sodium fluorophosphate (DB09484)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
Study: NCT01237977
Drug: Botulinum Toxin Type A(Meditoxin®)
Normalized name: Botulinum toxin type A
DrugBank: Botulinum toxin type A (DB00083)
Approvals — FDA: no, EMA: yes, PMDA: yes
Description: single administration, Day 0, 20U
Study: NCT01237977
Drug: Botulinum Toxin Type A(Botox®)
Normalized name: Botulinum toxin type A
DrugBank: Botulinum toxin type A (DB00083)
Approvals — FDA: no, EMA: yes, PMDA: yes
Description: single administration, Day 0, 20U
Study: NCT00071968
Drug: temsirolimus
Normalized name: Temsirolimus
DrugBank: Temsirolimus (DB06287)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT02109172
Drug: TD-4208
Normalized name: triamcinolone diacetate Injectable Suspension [TDS Forte]
DrugBank: Triamcinolone (DB00620)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03682705
Drug: Placebo for elsubrutinib
DrugBank: Rutin (DB01698)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsule for elsubrutinib will be administered orally.
Study: NCT03682705
Drug: Placebo for upadacitinib
Normalized name: Upadacitinib
DrugBank: Upadacitinib (DB15091)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Placebo tablet for upadacitinib will be administered orally.
Study: NCT00265330
Drug: Ziprasidone oral capsules
Normalized name: ziprasidone Oral Capsule
DrugBank: Ziprasidone (DB00246)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .
Study: NCT02283489
Drug: recombinant human endostatin adenovirus
Normalized name: Human adenovirus b serotype 7
DrugBank: Endostatin (DB06423)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Specification: 1mL/division, 1.0×1012 virus particle (VP). ESD01 preparation: Thaw at room temperature, dilute with normal saline to required volume (no more than 2 mL).~Method of administration: Intratumor injection, once a week for 2 weeks, every 3 weeks for one cycle. Select only one target lesion even when lesions are present. The target lesion is the largest and easiest to inject. This will be fixed during the study.
Study: NCT02283489
Drug: Cisplatin injection
Normalized name: cisplatin Injection
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Specification: 2ml: 10mg. Usage: 25mg/m2, days 1 to 3, according to instruction.
Study: NCT02283489
Drug: Paclitaxel injection
Normalized name: paclitaxel Injection
DrugBank: Paclitaxel (DB01229)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Specification: 5ml: 30mg. Usage: 160mg/m2 intravenously on day 1, according to instruction.
Study: NCT00210327
Drug: Bortezomib (drug)
Normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT02173730
Drug: BIBR 1048 MS
Normalized name: MS-1819
DrugBank: MS-1819 (DB15004)
Approvals — FDA: no, EMA: no, PMDA: no
Description: BIBR 1048 MS capsule 150 mg
Study: NCT02173730
Drug: Pantoprazole
Normalized name: Pantoprazole
DrugBank: Pantoprazole (DB00213)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Pantoprazole tablet 40 mg
Study: NCT01576718
Drug: Fp MDPI
Normalized name: Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP)
DrugBank: Albutrepenonacog alfa (DB13884)
Approvals — FDA: no, EMA: yes, PMDA: yes
Description: Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.~During the treatment period, participants were randomized to 50, 100, 200 or 400 mcg of Fp one inhalation twice a day for a total daily dose of 100, 200, 400 or 800 mcg. Study drug was administered in the morning and in the evening.
Study: NCT01576718
Drug: Flovent Diskus
Normalized name: Flovent Diskus
DrugBank: Fluticasone propionate (DB00588)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 250 mcg was used twice a day, once in the morning and evening, for a total daily dose of 500 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.
Study: NCT01576718
Drug: albuterol/salbutamol
DrugBank: Albuterol (DB01001)
Approvals — FDA: no, EMA: no, PMDA: no
Description: A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Study: NCT02478125
Drug: Burixafor Hydrobromide
Normalized name: hydrobromic acid
DrugBank: Burixafor (DB11970)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Investigators will determine the kinetics of PCa cell release into the blood with four daily dosages of Burixafor hydrobromide alone or in combination with G-CSF
Study: NCT02478125
Drug: Docetaxel
Normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Investigators will administer a single 75 mg/m2 IV dose of docetaxel. Twenty-one days later investigators will re-treat enrolled men with the optimal mobilization strategy + docetaxel IV. The second dose of docetaxel being given in combination with the optimal mobilization strategy will be chosen according to a standard 3+3 dose escalation schema, in which the dose of bruixafor +/- G-CSF will be held constant and the dose of docetaxel will escalate between three dose-levels: 1) docetaxel 30 mg/m2 IV, 2) docetaxel 60 mg/m2 IV, and 3) docetaxel 75 mg/m2
Study: NCT02478125
Drug: G-CSF
Normalized name: G-CSF
DrugBank: Filgrastim (DB00099)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: G-CSF will be given as a daily subcutaneous (SC) injection beginning 4 days prior to Burixafor hydrobromide and continuing through the 4 days of Burixafor hydrobromide treatment
Study: NCT00595972
Drug: ECF-endostar
Normalized name: Menostar
DrugBank: Endostar (DB11727)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Epirubicin 50mg/M2 D1, Cisplatin 60mg/M2 D1, FU 500mg/M2 D1-5, endostar 7.5mg/M2 D1-14, treatment cycle repeat every 3 weeks. Treatment should be continued until disease progression or intolerable toxicity or patients withdrawal of consent