TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01737671
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 5 mg/square meter per dose administered every 6 hours by vein or mouth.
Study: NCT00385710
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT01998776
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Starch four times daily
Study: NCT01669226
Drug: TCiv
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Study: NCT02950259
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: One dose of cyclophosphamide 300 mg/m2 IV infusion
Study: NCT02950259
Drug: Indomethacin
Normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Indomethacin 25 mg three times a day for 21 days
Study: NCT01135641
Drug: Corticosteroids
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00025896
Drug: recombinant human acid alpha-glucosidase (rhGAA)
Normalized name: alpha glucosidase
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00527800
Drug: Artemether-lumefantrine
Normalized name: artemether-lumefantrine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dosed twice daily for 3 days, given in fixed dose tablets (20 mg artemether + 120 mg lumefantrine) according to weight-based guidelines
Study: NCT01453075
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo twice daily
Study: NCT01684969
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.5 mg iv , one dose
Study: NCT03931408
Drug: Gentamicin Sulfate
Normalized name: Gentamicin Sulfate
DrugBank: Gentamicin (DB00798)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Gentamicin will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.
Study: NCT04644068
Drug: AZD5305
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral PARP inhibitor
Study: NCT04500509
Drug: diclofenac potassium + dinoprostone
Normalized name: Diclofenac Potassium
DrugBank: Diclofenac (DB00586)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure by the patient
Study: NCT04500509
Drug: diclofenac potassium + placebo
Normalized name: Diclofenac Potassium
DrugBank: Diclofenac (DB00586)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure by the patient
Study: NCT04289662
Drug: K-924 LD
Normalized name: K
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pitavastatin 2 mg / Ezetimibe 10 mg tables
Study: NCT04289662
Drug: K-924 HD
Normalized name: K
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pitavastatin 4 mg / Ezetimibe 10 mg tables
Study: NCT02246478
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: * Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals~* Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
Study: NCT01230580
Drug: Protease Inhibitor
Normalized name: Protease inhibitor
Approvals — FDA: no, EMA: no, PMDA: no
Description: Switch to a regimen comprising a single ritonavir-boosted Protease Inhibitor
Study: NCT01230580
Drug: Standard-of-care Antiretroviral therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Regimen should consist of 3 drugs: 2 nucleoside reverse transcriptase inhibitors with either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor
Study: NCT03840057
Drug: Azithromycin Injection
Normalized name: azithromycin Injection
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Azithromycin, a semi-synthetic macrolide antibiotic derived from erythromycin. The role of azithromycin as a prokinetic agent was first reported in a retrospective cohort study, which showed azithromycin to be equivalent to erythromycin in accelerating gastric emptying in patients with gastroparesis. The aim of this intervention arm is to evaluate the effectiveness of azithromycin as a prokinetic agent in the management of UGIB.
Study: NCT02465567
Drug: BGF MDI 320/14.4/9.6 μg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Budensonide, Glycopyrronium, and Formoterol Fumarate
Study: NCT02465567
Drug: GFF MDI 14.4/9.6 μg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Glycopyrronium, and Formoterol Fumarate
Study: NCT02465567
Drug: BGF MDI 160/14.4/9.6 μg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Budensonide, Glycopyrronium, and Formoterol Fumarate
Study: NCT03879278
Drug: NPT189
Approvals — FDA: no, EMA: no, PMDA: no
Description: NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis.
Study: NCT03478930
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.
Study: NCT02224144
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo (sugar pill) 1 pill per day for 12 months
Study: NCT03505008
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Route of Administration: Oral
Study: NCT02940912
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: cross-over with start with.Physiologic Serum in the 1st phase- in the 2nd phase of continuous treatment with Apokinon.
Study: NCT02098967
Drug: RO6839921
Approvals — FDA: no, EMA: no, PMDA: no
Description: Non-escalating IV doses given on Days 1-5 of Cycle 1.
Study: NCT02098967
Drug: RO6839921
Approvals — FDA: no, EMA: no, PMDA: no
Description: Escalating IV doses of RO6839921 in solid tumor patients. Dose escalation will be calculated using the new Continual Reassessment Method (nCRM). RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.
Study: NCT02098967
Drug: RO6839921
Approvals — FDA: no, EMA: no, PMDA: no
Description: Escalating IV doses of RO6839921 in AML patients. Escalation will follow an adapted rolling 6 design. Starting dose \</= dose inducing Grade 2 toxicity in patients with solid tumors. RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.
Study: NCT01164813
Drug: Nabumetone
Normalized name: Nabumetone
DrugBank: Nabumetone (DB00461)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
Study: NCT02576249
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4cc of sterile normal saline (0.9%)
Study: NCT01095926
Drug: doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: blood sampling before, during and after doxorubicin administration
Study: NCT03671044
Drug: Taxotere® (100 mg/m2)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Docetaxel Injection Concentrate; 20 mg/0.5 mL
Study: NCT01314105
Drug: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Approvals — FDA: no, EMA: no, PMDA: no
Description: BIBF1120 twice daily along with standard therapy of PLD + carboplatin
Study: NCT01314105
Drug: BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Approvals — FDA: no, EMA: no, PMDA: no
Description: BIBF1120 twice daily along with standard therapy of PLD + carboplatin
Study: NCT02179866
Drug: RO5285119
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) \[14C\]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1
Study: NCT02632331
Drug: ASP8825
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral
Study: NCT01934023
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03928496
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck
Study: NCT02019693
Drug: INC280
Approvals — FDA: no, EMA: no, PMDA: no
Description: Supplied by Novartis as film-coated tablet for oral use.
Study: NCT04046094
Drug: Ascorbic Acid
Normalized name: Ascorbic Acid
DrugBank: Ascorbic acid (DB00126)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Ascorbic Acid Intravenous
Study: NCT03083171
Drug: Endotoxin
Normalized name: Endotoxin
Approvals — FDA: no, EMA: no, PMDA: no
Description: At T=0 1 ng/kg E. Coli type O113 lipopolysaccharide is administrated intravenously as a bolus, followed by 1 ng/kg/hour for 3 hours.
Study: NCT03083171
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: At T=1 hour, placebo will be administered intravenously over a 1 hour period. Placebo is indistinguishable from Adrecizumab.
Study: NCT01500577
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Simvastatin 20 mg (capsules). 20mg/die every day for 1 year. Oral administration
Study: NCT01826188
Drug: THC 5mg/ml and CBS 50mg/ml
Approvals — FDA: no, EMA: no, PMDA: no
Description: olive oil containing THC and CBD
Study: NCT01826188
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: olive oil without cannabis
Study: NCT02238145
Drug: Atrovent® Inhaletten
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00332163
Drug: FOLFIRI
Approvals — FDA: no, EMA: no, PMDA: no
Description: Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.
Study: NCT00332163
Drug: Pre-emptive Skin Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily).
Study: NCT00332163
Drug: Reactive Skin Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine)
Study: NCT03478657
Drug: Placebo DPI
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will receive placebo via oral inhalation route using ELLIPTA once daily. Placebo DPI will be available in two strips of 30 blisters per strip. First strip will contain lactose monohydrate and second strip will have lactose monohydrate blended with magnesium stearate.
Study: NCT04201093
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
Study: NCT01345045
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo twice daily for 6 weeks.
Study: NCT01622998
Drug: Nicorette Inhaler
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day
Study: NCT03677648
Drug: SHR0302
Approvals — FDA: no, EMA: no, PMDA: no
Description: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Study: NCT03677648
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebos
Study: NCT00981357
Drug: Naproxen
Normalized name: Naproxen
DrugBank: Naproxen (DB00788)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Naproxen 500 mg tablet twice daily / matched placebo
Study: NCT01561274
Drug: 1.5 ml bupivicaine.
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1.5 ml bupivicaine.
Study: NCT02693210
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17
Study: NCT02693210
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Participants will receive \>= 10 mg/week methotrexate orally up to 24 weeks
Study: NCT02502110
Drug: rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: All recruited patients with paroxysmal atrial fibrillation will be randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before ablation and last for 3 months.
Study: NCT03018366
Drug: 17beta Estradiol
Normalized name: Estradiol-17beta
DrugBank: Estradiol (DB00783)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.
Study: NCT03018366
Drug: Placebo Pill
Normalized name: placebo Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
Study: NCT00559481
Drug: therapeutic hydrocortisone
Normalized name: Moisturel Therapeutic
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04070573
Drug: acetylsalicylic acid
Normalized name: ACETYLSALICYLIC ACID
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: High risk pregnant women will be treated with daily aspirin during pregnancy.
Study: NCT02899338
Drug: BI695501 Prefilled syringe
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02899338
Drug: BI695501Autoinjector
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01786668
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
Study: NCT00006734
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT01591759
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo arm of single-blind study
Study: NCT00006734
Drug: doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT04561466
Drug: Béfizal
Approvals — FDA: no, EMA: no, PMDA: no
Description: 600 mf befizal a day for one year
Study: NCT02242292
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03675477
Drug: SHR0302
Approvals — FDA: no, EMA: no, PMDA: no
Description: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a Janus kinase inhibitor).
Study: NCT03675477
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo Oral Tablet
Study: NCT01251237
Drug: NRL0706
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients receive 1 litre of NRL0706 solution followed by 0.5 litre of clear liquid during the afternoon/evening prior to colonoscopy. Patients receive 1 litre of 0706 solution followed by 0.5 litre of clear liquid during the morning of colonoscopy.
Study: NCT00302952
Drug: Lovastatin
Normalized name: Lovastatin
DrugBank: Lovastatin (DB00227)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion
Study: NCT00302952
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion
Study: NCT01245322
Drug: lactobacilli
Normalized name: lactobacillic acid
Approvals — FDA: no, EMA: no, PMDA: no
Description: women were given a seven days course of daily 2% vaginal clindamycin cream (Dalacin vaginal cream 2%, Pfizer Norway Ltd) together with oral clindamycin 300 mg BID for 7 days (Dalacin 300 mg, Pfizer Norway Ltd). Oral clindamycin treatment was also given to the patient's sexual partner.
Study: NCT01849783
Drug: doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT01849783
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV or PO
Study: NCT02126995
Drug: MG01CI extended-release tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: Metadoxine, MG01CI extended-release tablet taken for 6 weeks treatment. Starting with a dose of 700 mg for 2 weeks followed by a 2 weeks of 1400 mg and then 2 weeks of 700 mg or 1400 mg.
Study: NCT00406848
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
Study: NCT02796469
Drug: Corticosteroid
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02796469
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02143466
Drug: Part B - AZD9291 in combination with AZD6094
Normalized name: haemophilus influenzae B, combinations with toxoids
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part B - AZD9291 and AZD6094 administered in the dose identified in Part A (AZD9291 80mg OD + AZD6094 600mg OD) to further investigate the safety and tolerability of this combination.
Study: NCT03392909
Drug: Gentamicin
Normalized name: Gentamicin
DrugBank: Gentamicin (DB00798)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Short-term intravenous gentamicin therapy should have the advantage of treating all of the patient's multiple skin wounds simultaneously. Six patients (three adults and 3 children) will receive intravenous gentamicin (7.5 mgs/kg) daily for 14 days and then stopped. Three adult patients will receive intravenous gentamicin (7.5mg/kg) biweekly for three months and then stopped.
Study: NCT02143466
Drug: Part B - AZD9291 in combination with MEDI4736
Normalized name: haemophilus influenzae B, combinations with toxoids
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part B - AZD9291 and MEDI4736 administered in the dose identified in Part A to further investigate the safety and tolerability of this combination.~Note: Enrolment into the patient cohort that evaluated AZD9291 treatment in combination with MEDI4736 as 1st line treatment has been terminated due to an increased incidence of ILD-like events (interstitial lung disease/pneumonitis), and is no longer being evaluated in this study.
Study: NCT02143466
Drug: Part C - AZD9291 in combination with AZD6094 (Japan only)
Normalized name: vitamin C combinations
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part C combination cohort - AZD9291 80mg OD administered in combination with AZD6094 400mg OD (AZD6094 dose in which DLTs have not been identified in the Japanese monotherapy cohort) in order to confirm the safety, tolerability, pharmacokinetics and preliminary anti-tumor activities of this combination in Japanese subjects. The 400mg OD dosing schedule will be initiated in the first cohort. The dose may be subsequently reduced in further cohorts in response to emerging safety, or PK findings or other reasons identified in the savolitinib programme.
Study: NCT02143466
Drug: Part D - AZD9291 in combination with AZD6094
Normalized name: Calcium, combinations with vitamin D and/or other drugs
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part D - AZD9291 80mg OD administered in combination with AZD6094 300mg OD to further evaluate the safety, tolerability, pharmacokinetics and antitumor activity in terms of ORR and PFS in patients with locally advanced or metastatic cMET positive EGFRm+ and T790M-negative NSCLC, following progression on EGFR-TKI treatment. The choice of AZD6094 dose of 300 mg is based on results from preclinical and clinical studies. Clinical testing of the 300 mg OD dose will enable better assessment of impact of lower AZD6094 exposure on overall tolerability and hepatotoxicity risk as well as exploration of the efficacy and overall safety profiles with a dose meaningfully lower than the current dose of 600 mg OD.
Study: NCT04314726
Drug: Amelogenin
Normalized name: amelogenin protein matrix, porcine derived
Approvals — FDA: no, EMA: no, PMDA: no
Description: amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction
Study: NCT04314726
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo applied on the distal surface of the lower second molar after adjacent third molar extraction
Study: NCT03694587
Drug: Ibuprofen 200 mg TEPI Medicated Plaster
Normalized name: ibuprofen 200 MG
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Ibuprofen 200mg TEPI medicated plaster applied to the upper back daily for 24 hours for 5 days
Study: NCT03694587
Drug: Aktren® 200 mg überzogene Tabletten (Ibuprofen)
Approvals — FDA: no, EMA: no, PMDA: no
Description: one dose of Aktren® 200 mg überzogene Tabletten (Ibuprofen tablet)
Study: NCT03920007
Drug: 1% Prednisolone
DrugBank: Prednisolone (DB00860)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Pharmaceutical form:Suspension Route of administration: Drops
Study: NCT00163449
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT02051309
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01718938
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no