AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT02394665
Drug: Temozolomide
RxNorm normalized name: Temozolomide
DrugBank: Temozolomide (DB00853)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Concurrently during radiation therapy. Adjuvant therapy administered daily on days 1 - 5 for 12 cycles. One cycle = 28 days:~* Concurrent during Radiation Therapy: 75 mg/m\^2 orally for 6 weeks;~* Post-radiation, adjuvant therapy: 150 mg/m\^2 - 200 mg/m\^2 orally daily on days 1 - 5 of each cycle.
Trial: NCT00627354
Drug: etoposide
RxNorm normalized name: Etoposide
DrugBank: Etoposide (DB00773)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00627354
Drug: mitoxantrone hydrochloride
RxNorm normalized name: Mitoxantrone Hydrochloride
DrugBank: Mitoxantrone (DB01204)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00627354
Drug: prednisone
RxNorm normalized name: Prednisone
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00627354
Drug: vinorelbine tartrate
RxNorm normalized name: Vinorelbine Tartrate
DrugBank: Vinorelbine (DB00361)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01621204
Drug: Eltrombopag
RxNorm normalized name: Eltrombopag
DrugBank: Eltrombopag (DB06210)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Participants are started on 50mg daily oral pill (or 25mg daily for patients of East Asian descent) 21 days before surgery. Dose may be adjusted based on subsequent platelet counts (minimum 25mg; maximum 75mg).
Trial: NCT01621204
Drug: IVIG infusion
RxNorm normalized name: Duo Fusion
DrugBank: Famotidine (DB00927)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IVIG infusion (1-2 g/kg) given 7 (+/-2) days prior to surgery; with an additional infusion allowed within one week of achievement of surgical hemostasis, if needed
Trial: NCT03383003
Drug: Nexium
RxNorm normalized name: Nexium
DrugBank: Esomeprazole (DB00736)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Esomeprazole ( Nexium )40 mg tid daily for 14 days in the high dose dual therapyarm and 40 mg bid daily for 7 days in the non-bismuth quadruple therapy
Trial: NCT02780895
Drug: Human Stem Cells
RxNorm normalized name: Allogeneic human mesenchymal stem cell
DrugBank: Remestemcel-L (DB13973)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: MRI-guided stereotactic intraputaminal cell implantation into PD patients was performed.~For target locations, measurements were made using CT-scan images fused with previous MR images. Bilateral parasagittal incisions and corresponding 14 mm burr holes were made in preparation for cell suspension injections.~To ensure complete cell suspension delivery, injections were carried out slowly for 2 min with reciprocal withdrawal of the delivery needle to avoid both damage to stem cells and brain tissue, as well as to avert reflux or bubble formation.~After surgery, patients were kept in a conventional post-operative care unit for 1 h. The day following surgery, MR images were obtained to confirm correct placement of cell suspensions. All patients were discharged 24 h after surgery.
Trial: NCT04639986
Drug: Sacituzumab Govitecan-hziy
RxNorm normalized name: sacituzumab govitecan-hziy
DrugBank: Sacituzumab govitecan (DB12893)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Sacituzumab govitecan 10 mg/kg via IV injection administered on Days 1 and 8 of a 21-day cycle. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Trial: NCT04639986
Drug: Eribulin Mesylate Injection
RxNorm normalized name: Eribulin Mesylate Injection
DrugBank: Eribulin (DB08871)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Trial: NCT04639986
Drug: Gemcitabine Injection
RxNorm normalized name: gemcitabine Injection
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Trial: NCT04639986
Drug: Vinorelbine injection
RxNorm normalized name: vinorelbine Injection
DrugBank: Vinorelbine (DB00361)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
Trial: NCT01486381
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 subcutaneously (s.c., under the skin)
Trial: NCT04786756
Drug: Bupivacaine 0.25% Injectable Solution
RxNorm normalized name: BUPivacaine 0.25% injectable solution
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 mg/kg Bupivacaine (0.25%)
Trial: NCT03383003
Drug: Amolin
RxNorm normalized name: Ethamolin
DrugBank: Amoxicillin (DB01060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Amoxicillin 750 mg qid daily for 14 days in the high dose dual therapy and amoxicillin 1 g bid daily for 7 days in the non-bismuth quadruple therapy
Trial: NCT01098526
Drug: Efavirenz
RxNorm normalized name: Efavirenz
DrugBank: Efavirenz (DB00625)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Efavirenz is a drug that has been approved by the FDA for the treatment of HIV. It is in the class of non-nucleoside reverse trancriptase inhibitors.
Trial: NCT03383003
Drug: Flagyl
RxNorm normalized name: Flagyl
DrugBank: Metronidazole (DB00916)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Metronidazole (Flagyl) 500 mg tid daily for 7 days in the non-bismuth quadruple therapy
Trial: NCT00814645
Drug: Sodium Nitrite Inhalation Solution
RxNorm normalized name: Sodium Nitrite
DrugBank: Sodium citrate (DB09154)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Trial: NCT00338260
Drug: Comparator : atenolol /Duration of Treatment : 5 Years
DrugBank: Atenolol (DB00335)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03512119
Drug: Lumacaftor-Ivacaftor treatment
DrugBank: Ivacaftor (DB08820)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Lumacaftor-Ivacaftor treatment during one year
Trial: NCT00257868
Drug: Rivastigmine prevention of delirium
RxNorm normalized name: Rivastigmine
DrugBank: Rivastigmine (DB00989)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT00005675
Drug: Oral bovine type I collagen
RxNorm normalized name: Bovine type I collagen
DrugBank: Bovine type I collagen (DB10771)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 500 mcg of CI daily for 15 months
Trial: NCT01155791
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IV 75 mg/m2
Trial: NCT01155791
Drug: Prednisone
RxNorm normalized name: Prednisone
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 5mg, orally
Trial: NCT02729935
Drug: Parecoxib
RxNorm normalized name: parecoxib
DrugBank: Parecoxib (DB08439)
FDA approved: no
EMA approved: yes
PMDA approved: no
Description: 40 mg of intravenous parecoxib 30 min before surgery
Trial: NCT00288522
Drug: Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days
DrugBank: Lanreotide (DB06791)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00049400
Drug: BMS-247550
RxNorm normalized name: BMS dasatinib
DrugBank: Dasatinib (DB01254)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle
Trial: NCT02039661
Drug: Lidocaine Spray
RxNorm normalized name: lidocaine Mucosal Spray
DrugBank: Lidocaine (DB00281)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: These patients received 2 puff lidocaine spray
Trial: NCT00914290
Drug: Baclofen IR
RxNorm normalized name: Baclofen
DrugBank: Baclofen (DB00181)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Encapsulated baclofen tablet 5 mg per capsule
Trial: NCT00280865
Drug: Tesaglitazar
RxNorm normalized name: Tesaglitazar
DrugBank: Tesaglitazar (DB06536)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00280865
Drug: Pioglitazone
RxNorm normalized name: Pioglitazone
DrugBank: Pioglitazone (DB01132)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03023423
Drug: Atezolizumab
RxNorm normalized name: Atezolizumab
DrugBank: Atezolizumab (DB11595)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Participants will receive atezolizumab 1200 mg intravenously.
Trial: NCT03023423
Drug: Daratumumab
RxNorm normalized name: Daratumumab
DrugBank: Daratumumab (DB09331)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive daratumumab 16 mg/kg intravenously.
Trial: NCT00801411
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT01498783
Drug: 5-fluorouracil
RxNorm normalized name: 5-fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 5-fluorouracil, bolus dose of 500 mg/m\^2 given weekly for 4 weeks followed by a two week rest period equals one cycle (6 weeks). Therapy may continue for up to 16 cycles (about 2 years).
Trial: NCT00484276
Drug: NGR-hTNF
RxNorm normalized name: NGR-hTNF
DrugBank: Tengonermin (DB16689)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
Trial: NCT02146222
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT01444898
Drug: Exenatide
RxNorm normalized name: Exenatide
DrugBank: Exenatide (DB01276)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
Trial: NCT00066508
Drug: bortezomib
RxNorm normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT04292314
Drug: Omega 3
RxNorm normalized name: omega 3,6
DrugBank: Capsaicin (DB06774)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Omega-3 supplementation (300-400mg EPA \& 200-300mg DHA) per day for 8 consecutive months up to 10 months
Trial: NCT04022005
Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy.~Patients with CR or PR will receive chidamide maintenance therapy.
Trial: NCT01227928
Drug: Pazopanib
RxNorm normalized name: Pazopanib
DrugBank: Pazopanib (DB06589)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Pazopanib 800 mg daily for 24 months
Trial: NCT01084993
Drug: Bivalirudin
RxNorm normalized name: Bivalirudin
DrugBank: Bivalirudin (DB00006)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
Trial: NCT04292314
Drug: Hydroxyurea
RxNorm normalized name: Hydroxyurea
DrugBank: Hydroxyurea (DB01005)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
Trial: NCT04292314
Drug: Honey
RxNorm normalized name: Honey
DrugBank: Honey (DB14242)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
Trial: NCT04292314
Drug: Deferoxamine
RxNorm normalized name: Deferoxamine
DrugBank: Deferoxamine (DB00746)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: deferoxamine (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.
Trial: NCT05988034
Drug: Avacopan
RxNorm normalized name: Avacopan
DrugBank: Avacopan (DB15011)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Administered orally.
Trial: NCT05988034
Drug: Moxifloxacin
RxNorm normalized name: Moxifloxacin
DrugBank: Moxifloxacin (DB00218)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Administered orally.
Trial: NCT05988034
Drug: Placebo for avacopan
RxNorm normalized name: Avacopan
DrugBank: AVAC (DB05441)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Administered orally.
Trial: NCT05988034
Drug: Placebo for moxifloxacin
DrugBank: Moxifloxacin (DB00218)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Administered orally.
Trial: NCT01267981
Drug: Standard Diet + 500 ml of polyethyleneglycol
RxNorm normalized name: DIET FORMULATIONS FOR TREATMENT OF OBESITY
DrugBank: Poly(lactic acid) (DB15037)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
Trial: NCT01267981
Drug: Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol
RxNorm normalized name: Polyethylene Glycol
DrugBank: Polyethylene glycol (DB09287)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: apply the standard diet and drink 2 liters of polyethylene glycol between 19h and 21h the day before exploration. Then drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
Trial: NCT03192969
Drug: Abatacept
RxNorm normalized name: Abatacept
DrugBank: Abatacept (DB01281)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)
Trial: NCT04643093
Drug: Pitavastatin
RxNorm normalized name: Pitavastatin
DrugBank: Pitavastatin (DB08860)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Pitavastatin, QD
Trial: NCT04643093
Drug: Ezetimibe
RxNorm normalized name: Ezetimibe
DrugBank: Ezetimibe (DB00973)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Ezetimibe, QD
Trial: NCT01633476
Drug: Valaciclovir
RxNorm normalized name: valaciclovir
DrugBank: Valaciclovir (DB00577)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 2g q.d.s. orally for 6 months (dose adjusted according to renal function)
Trial: NCT00338988
Drug: Oxaliplatin
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 130 mg/m\^2 IV over 2 hours on day 1 of cycle.
Trial: NCT00503724
Drug: enzastaurin hydrochloride
RxNorm normalized name: Chlorpromazine Hydrochloride
DrugBank: Enzastaurin (DB06486)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants receive 200, 260, 340, or 440 mg/m2/day of enzastaurin orally once daily for 28 days (one course) during the dose escalation phase of the study. To study the toxicity profile of the MTD or phase II recommended dose established during the dose escalation phase, participants receive twice daily doses of enzastaurin orally at the phase II recommended dose for 28 days (one course). In the absence of unacceptable toxicity or disease progression, treatment may continue for 13 courses (approximately one year).
Trial: NCT03293069
Drug: Deferiprone
RxNorm normalized name: Deferiprone
DrugBank: Deferiprone (DB08826)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: One 600 mg delayed-release tablets of deferiprone twice a day, for at 30 mg/kg/day
Trial: NCT01227616
Drug: Ferumoxytol
RxNorm normalized name: Ferumoxytol
DrugBank: Ferumoxytol (DB06215)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: IV Ferumoxytol
Trial: NCT01227616
Drug: Iron Sucrose
RxNorm normalized name: Iron Sucrose
DrugBank: Iron sucrose (DB09146)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IV Iron Sucrose
Trial: NCT01431950
Drug: fluticasone furoate
RxNorm normalized name: Fluticasone Furoate
DrugBank: Fluticasone furoate (DB08906)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Inhaled corticosteroid
Trial: NCT01431950
Drug: albuterol/salbutamol
DrugBank: Albuterol (DB01001)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Provided as rescue relief of asthma symptoms
Trial: NCT02101983
Drug: Cytosine Arabinoside
RxNorm normalized name: Cytosine arabinoside
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01611961
Drug: DT-LM
RxNorm normalized name: L-DT
DrugBank: Telbivudine (DB01265)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Intravenous infusion, Upto 6 dose levels have been studied i.e. 45, 60, 75, 90 105,and 120 mg/m2, Every 3 weeks.
Trial: NCT01611961
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intravenous infusion, 3 dose levels：60, 75, and 90 mg/m2, Every 3 weeks
Trial: NCT02237339
Drug: Allopurinol
RxNorm normalized name: Allopurinol
DrugBank: Allopurinol (DB00437)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Uric acid lowering medication.
Trial: NCT00405704
Drug: Trimethoprim-Sulfamethoxazole
RxNorm normalized name: sulfamethoxazole / trimethoprim
DrugBank: Trimethoprim (DB00440)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
Trial: NCT03135262
Drug: Idasanutlin
RxNorm normalized name: Idasanutlin
DrugBank: Idasanutlin (DB12325)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Induction Treatment: Idasanutlin tablets will be administered orally once daily at escalated doses (starting dose 100 milligrams \[mg\], maximum 600 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.
Trial: NCT03135262
Drug: Obinutuzumab
RxNorm normalized name: Obinutuzumab
DrugBank: Obinutuzumab (DB08935)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Participants will receive a fixed dose of obinutuzumab, 1000 mg by intravenous (IV) infusion on Days 1, 8 and 15 of Cycle 1 and on Day 1 of each subsequent cycle (Cycles 2 to 6) (each cycle = 28 days) during induction treatment, and on Day 1 of every other month during maintenance treatment (eligible participants with FL only) or during consolidation treatment (eligible participants with DLBCL only).
Trial: NCT03135262
Drug: Venetoclax
RxNorm normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Induction Treatment: Venetoclax tablets will be administered orally once daily at escalated doses (starting dose 200 mg, maximum 800 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.
Trial: NCT03135262
Drug: Rituximab
RxNorm normalized name: Rituximab
DrugBank: Rituximab (DB00073)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m\^2) on Day 1 of Cycles 1-6 during induction treatment and on Day 1 of every other month during consolidation treatment.
Trial: NCT04880993
Drug: Dapagliflozin 10 mg tablets
RxNorm normalized name: dapagliflozin
DrugBank: Dapagliflozin (DB06292)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd
Trial: NCT02680119
Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg
DrugBank: Omeprazole (DB00338)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: oral, crossover
Trial: NCT00028639
Drug: bortezomib
RxNorm normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT00920647
Drug: Idursulfase IT (1 mg)
RxNorm normalized name: Idursulfase
DrugBank: Idursulfase (DB01271)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: The original design of the study was to test the dose levels of 10, 30 and 100 mg. This was based on a calculation of a minimally effective dose around 10 mg, with subsequent dose levels being chosen as increasing half-log steps. During the conduct of the study; however, it became clear that the 10 mg dose elicited a strong Pharmacodynamic response, as measured by a dramatic and sustained drop in the CSF GAG levels. This indicated the need to explore a lower level as a minimally effective dose level, leading to the introduction of the 1 mg group. Enrollment of patients in this dose cohort will commence after the last patient has been enrolled in 30 mg dose cohort. 4 patients will be undergo surgical placement of an IDDD and receive 1 mg idursulfase-IT as an IT injection via an IDDD once per month (ie, every 28 days) for 6 month.
Trial: NCT00920647
Drug: Idursulfase IT (10 mg)
RxNorm normalized name: Idursulfase
DrugBank: Idursulfase (DB01271)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients will be enrolled in 10 mg dose cohort and 30 mg dose cohort in a sequential, escalating fashion. 4 patients will undergo surgical placement of an IDDD and receive 10 mg idursulfase-IT as an intrathecal (IT) injection via an IDDD once per month (ie, every 28 days) for 6 month.
Trial: NCT00920647
Drug: Idursulfase IT (30 mg)
RxNorm normalized name: Idursulfase
DrugBank: Idursulfase (DB01271)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients will be enrolled in 10 mg dose cohort and 30 mg dose cohort in a sequential, escalating fashion. 4 patients will undergo surgical placement of an IDDD and receive 30 mg idursulfase-IT as an IT injection via an IDDD once per month (ie, every 28 days) for 6 month.
Trial: NCT02105675
Drug: Docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Docetaxel is Standard of Care First Line Chemotherapy
Trial: NCT00393614
Drug: levetiracetam
RxNorm normalized name: Levetiracetam
DrugBank: Levetiracetam (DB01202)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 20 mg pr. kg a day
Trial: NCT00693433
Drug: dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given orally
Trial: NCT00693433
Drug: temsirolimus
RxNorm normalized name: Temsirolimus
DrugBank: Temsirolimus (DB06287)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given IV
Trial: NCT01215578
Drug: Sutent
RxNorm normalized name: Sutent
DrugBank: Sunitinib (DB01268)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: sunitinib 37.5 mg/day (per os) for 6 months
Trial: NCT02171247
Drug: Isovue 370
RxNorm normalized name: IOPAMIDOL 755 mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [ISOVUE 370]
DrugBank: Iopamidol (DB08947)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Isovue 370 is a contrast agent with increased iodine concentration.