TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00089284
Drug: motexafin gadolinium
Normalized name: Motexafin gadolinium
DrugBank: Motexafin gadolinium (DB05428)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2\*, 4\*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
Study: NCT00089284
Drug: 111Indium-Zevalin and 90Yttrium-Zevalin
Normalized name: 111Indium pentetreotide
DrugBank: Indium (DB11659)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2\*, 4\*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8.
Study: NCT00160030
Drug: 5-FU / Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: two cycles of 5-FU / Cisplatin on week 1 and 5 of radiotherapy and two cycles of chemotherapy with 5-FU / Cisplatin on week 8 and 11 (one cycle each three weeks after the end of radiotherapy).
Study: NCT01941043
Drug: CERC-301
Normalized name: CERC-301
DrugBank: CERC-301 (DB12063)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04951440
Drug: Nitrate ketone oxazine
Normalized name: Ketonal
DrugBank: Nitrate (DB14049)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intervention group: 30min intravenous point. Drop qiu was given 1400 mg of injected sichuan nitrone I bed, and the drug was given 100 mL at day F Set 12 h, and at odds with another 7 days, that is, about 14 times in total.
Study: NCT00005091
Drug: exatecan mesylate
Normalized name: mesylate
DrugBank: Exatecan (DB12185)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02683733
Drug: 5-Aminosalicylic acid
Normalized name: 5-aminosalicylic acid
DrugBank: Mesalazine (DB00244)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Dosage is as instructed by patient's physician
Study: NCT00054717
Drug: Tipranavir
Normalized name: Tipranavir
DrugBank: Tipranavir (DB00932)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT00054717
Drug: Ritonavir(r)
Normalized name: Ritonavir
DrugBank: Ritonavir (DB00503)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT04622735
Drug: Nefopam HCl 30 MG Oral Tablet X2
Normalized name: nefopam
DrugBank: Nefopam (DB12293)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
Study: NCT01149616
Drug: Dexamethasone 8mg iv x1
Normalized name: dexamethasone 8 MG
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Dexamethasone 8mg iv x1
Study: NCT02387814
Drug: Abemaciclib
Normalized name: Abemaciclib
DrugBank: Abemaciclib (DB12001)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Administered Orally
Study: NCT02806973
Drug: Nasal Glucagon
Normalized name: glucagon Nasal Powder
DrugBank: Glucagon (DB00040)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Administered intranasally.
Study: NCT02068456
Drug: Roflumilast
Normalized name: Roflumilast
DrugBank: Roflumilast (DB01656)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT02134301
Drug: Oritavancin
Normalized name: Oritavancin
DrugBank: Oritavancin (DB04911)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT03621085
Drug: Ketamine Hydrochloride
Normalized name: Ketamine Hydrochloride
DrugBank: Ketamine (DB01221)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A total of 20 mg of Ketamine Hydrochloride will be administered intravenously
Study: NCT01706692
Drug: Cyclosporine A
Normalized name: CycloSPORINE A
DrugBank: Cyclosporine (DB00091)
Approvals — FDA: no, EMA: no, PMDA: no
Description: all dosages, frequencies and durations prescribed
Study: NCT01706692
Drug: Fumaric acids
Normalized name: Fumaric Acid
DrugBank: Fumaric acid (DB01677)
Approvals — FDA: no, EMA: no, PMDA: no
Description: all dosages, frequencies and durations prescribed
Study: NCT01706692
Drug: Other anti-psoriatic systemic treatments
Normalized name: benzoyl peroxide
DrugBank: Benzoyl peroxide (DB09096)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: all dosages, frequencies and durations prescribed
Study: NCT00954226
Drug: Erlotinib Hydrochloride
Normalized name: Erlotinib Hydrochloride
DrugBank: Erlotinib (DB00530)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given PO
Study: NCT02086656
Drug: capecitabine, oxaliplatin, irinotecan and bevacizumab
DrugBank: Bevacizumab (DB00112)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: perioperative COI-B
Study: NCT03304821
Drug: GM-CSF
Normalized name: GM-CSF
DrugBank: Regramostim (DB05386)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will self-administer 500 μg/day of GM-CSF, subcutaneously, three times per week (Monday, Wednesday, Friday) for three weeks. After three months the participants will receive a second administration of 500 μg/day of subcutaneous GM-CSF, three times per week for another 3 weeks and then will be followed for another 3 months.
Study: NCT02402920
Drug: Carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT02402920
Drug: Cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT02402920
Drug: Etoposide
Normalized name: Etoposide
DrugBank: Etoposide (DB00773)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT02278341
Drug: Roxadustat
Normalized name: roxadustat
DrugBank: Roxadustat (DB04847)
Approvals — FDA: no, EMA: yes, PMDA: yes
Description: Participants received initial dose of roxadustat orally as a tablet in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
Study: NCT02278341
Drug: Epoetin alfa
Normalized name: epoetin alfa
DrugBank: Erythropoietin (DB00016)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants received epoetin alfa via intravenous or subcutaneous injection, once a week, twice a week, or three times a week (TIW). Epoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of epoetin alfa was per UK SmPC of Eprex®. Participants received IV iron supplementation according to the standard of care.
Study: NCT02278341
Drug: Darbepoetin alfa
Normalized name: Darbepoetin Alfa
DrugBank: Darbepoetin alfa (DB00012)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants received darbepoetin alfa via intravenous or subcutaneous injection, once a week or once every other week. Darbepoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of darbepoetin alfa was per EU SmPC of Aranesp®. Participants received IV iron supplementation according to the standard of care.
Study: NCT00165854
Drug: E7070
Normalized name: Capivasertib
DrugBank: Capivasertib (DB12218)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00846742
Drug: Stanford V Chemotherapy
Normalized name: Penicillin V
DrugBank: Phenoxymethylpenicillin (DB00417)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone
Study: NCT03838263
Drug: Nivolumab
Normalized name: Nivolumab
DrugBank: Nivolumab (DB09035)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 2 nivolumab infusion (240 mg IV) 2 weeks apart (on day 1 and day 15) followed by standard chemoradiation.
Study: NCT03778957
Drug: Durvalumab
Normalized name: Durvalumab
DrugBank: Durvalumab (DB11714)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Durvalumab IV (intravenous)
Study: NCT00162786
Drug: Rupatadine
Normalized name: Rupatadine
DrugBank: Rupatadine (DB11614)
Approvals — FDA: no, EMA: no, PMDA: yes
Study: NCT00162786
Drug: Hydroxyzine
Normalized name: Hydroxyzine
DrugBank: Hydroxyzine (DB00557)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03778957
Drug: Bevacizumab
Normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Bevacizumab IV (intravenous)
Study: NCT00427960
Drug: atorvastatin
Normalized name: Atorvastatin
DrugBank: Atorvastatin (DB01076)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: atorvastatin 10 mg
Study: NCT01363609
Drug: Liraglutide treatment 12 weeks
Normalized name: Liraglutide
DrugBank: Liraglutide (DB06655)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: liraglutide will be started with a titration period of 2 weeks: week 1 0.6mg once daily, week 2 1.2mg once daily. If well tolerated, treatment will be continued for 10 more weeks in dosage of 1.8mg once daily
Study: NCT01363609
Drug: insulin glargine treatment
Normalized name: Insulin Glargine
DrugBank: Insulin glargine (DB00047)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Insulin glargine treatment consist a treatment period of 12 weeks. Treatment will start with a dosage of 10 IU once daily. Patient will self-titrate the insulin glargine dosage based on self-monitored fasting blood glucose (FBG) concentrations for the previous 3 days using the following guideline: If FBG levels are above 5.6 mmol/L (100-153 mg/dL) on 3 consecutive mornings, the daily dose is to be increased by 2 IU/day. If hypoglycemia documented by glucose concentration \< 3.3 mmol/L (60 mg/dL) or requiring assistance occurs without an easily identifiable reason (skipped meal, excessive physical activity), the daily dose is to be downregulated, with -2 IU/day
Study: NCT01363609
Drug: GLP-1 receptor antagonist
Normalized name: Arg34Lys26-(N-ε-(γ-Glu(N-α-hexadecanoyl)))-GLP-1[7-37]
DrugBank: Liraglutide (DB06655)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Exendin 9-39 will be infused intravenously at doses of 600 pM/kg • min. This will only be during one of the visit for the healthy lean controls and the T2DM group, and during two visits in the group with obesity planned for gastric bypass surgery
Study: NCT02100852
Drug: TGR-1202 + Obinutuzumab + Chlorambucil
Normalized name: Obinutuzumab
DrugBank: Chlorambucil (DB00291)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose
Study: NCT01200394
Drug: PF-00489791
Normalized name: PF-00489791
DrugBank: PF-00489791 (DB11736)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablet, 20 mg once daily for 12 weeks
Study: NCT02962947
Drug: Propranolol
Normalized name: Propranolol
DrugBank: Propranolol (DB00571)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 80 mgR propranolol once daily
Study: NCT01591031
Drug: Sevoflurane
Normalized name: Sevoflurane
DrugBank: Sevoflurane (DB01236)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation
Study: NCT01591031
Drug: Rocuronium
Normalized name: Rocuronium
DrugBank: Rocuronium (DB00728)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation
Study: NCT02678897
Drug: Oxynorm on-demand
Normalized name: oxycodone hydrochloride Oral Capsule [Oxynorm]
DrugBank: Oxycodone (DB00497)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication)~1. If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) - 15 mg (over 80 kg) po. In an hour oxycodon 5-10 mg more po if needed. Intramuscular or intravenous administration if needed.~2. Patient controlled analgesia (PCA pain pump): Oxycodon dose is 3.0 mg (3 ml) and lock-out time 8 min. Maximum four doses in hour. Dose can be lowered or augmented 0,5 mg at time between 2.0-4.0 mg and maximal number of doses can be up to 5.
Study: NCT01965977
Drug: Bortezomib
Normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Bortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months
Study: NCT05767866
Drug: YK-029A
Normalized name: YK-4-279
DrugBank: YK-4-279 (DB17428)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Daily dose of YK-029A
Study: NCT00201669
Drug: Clofarabine
Normalized name: Clofarabine
DrugBank: Clofarabine (DB00631)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Clofarabine 30 mg/m2/day will be administered as a 2-hour intravenous infusion (IVI) on days 1-5.
Study: NCT01337154
Drug: Tamibarotene
Normalized name: Tamibarotene
DrugBank: Tamibarotene (DB04942)
Approvals — FDA: no, EMA: no, PMDA: yes
Description: Tablet, 6 mg/m2, oral, divided into twice a day dosing.
Study: NCT00202553
Drug: Perindopril
Normalized name: Perindopril
DrugBank: Perindopril (DB00790)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02902978
Drug: E6130
Normalized name: Eflornithine
DrugBank: Eflornithine (DB06243)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01653574
Drug: Famitinib Malate
Normalized name: malate
DrugBank: Famitinib (DB11741)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The starting dose of Famitinib Malate will be 25 mg/d. Two dose reductions will be allowed to 20 and then 15 mg/d.
Study: NCT04083339
Drug: AT-001
Normalized name: AT-001
DrugBank: AT-001 (DB15121)
Approvals — FDA: no, EMA: no, PMDA: no
Description: AT-001 will be administered as 3 capsules twice daily, before breakfast and before dinner.~At present AT001 is the sole name for the active substance. No INN/genetic name is available to date
Study: NCT03557827
Drug: Photodynamic Therapy with indocyanine green and diode laser
Normalized name: Indocyanine Green
DrugBank: Indocyanine green (DB16024)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: mechanical debridement by periodontal curets plus Indocyanine green solution activated by diode laser. The diode laser is classified as a Class I medical device according to the Directive 93/42/EEC
Study: NCT00423670
Drug: boceprevir (SCH 503034)
DrugBank: Boceprevir (DB08873)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 200 mg capsules taken as 800 mg orally three times daily (TID)
Study: NCT00423670
Drug: peginterferon-alfa 2b (PegIntron)
Normalized name: peginterferon alfa-2b Injection [Pegintron]
DrugBank: Cepeginterferon alfa-2B (DB12814)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1.5 μg/kg subcutaneously (SC) once weekly (QW)
Study: NCT00423670
Drug: ribavirin
Normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily
Study: NCT00423670
Drug: ribavirin (low-dose)
Normalized name: Ribavirin
DrugBank: Ribavirin (DB00811)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily
Study: NCT02049671
Drug: Growth Hormone Therapy
Normalized name: Growth hormone
DrugBank: Somatotropin (DB00052)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00608543
Drug: Aripiprazole
Normalized name: Aripiprazole
DrugBank: Aripiprazole (DB01238)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: varied dose (5, 10, 15 mg qd) for 6 wks
Study: NCT03613597
Drug: etoposide plus lobaplatin
Normalized name: Etoposide
DrugBank: Etoposide (DB00773)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus lobaplatin
Study: NCT03613597
Drug: etoposide plus cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus Cisplatin
Study: NCT00426998
Drug: Verteporfin
Normalized name: Verteporfin
DrugBank: Verteporfin (DB00460)
Approvals — FDA: yes, EMA: yes, PMDA: no
Study: NCT00426998
Drug: Bevacizumab
Normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Study: NCT01859702
Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
DrugBank: Moxifloxacin (DB00218)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT01825603
Drug: ADH-1
Normalized name: ADH-1
DrugBank: ADH-1 (DB05485)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given IV
Study: NCT01825603
Drug: Cisplatin
Normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT01743677
Drug: Moxifloxacin
Normalized name: Moxifloxacin
DrugBank: Moxifloxacin (DB00218)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Single dose Avelox 400 mg tablet
Study: NCT01825603
Drug: Gemcitabine Hydrochloride
Normalized name: Gemcitabine Hydrochloride
DrugBank: Gemcitabine (DB00441)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT03701321
Drug: Bortezomib
Normalized name: Bortezomib
DrugBank: Bortezomib (DB00188)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given SC
Study: NCT03701321
Drug: Dexamethasone
Normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given PO
Study: NCT03701321
Drug: Venetoclax
Normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Given PO
Study: NCT02753218
Drug: Midazolam
Normalized name: Midazolam
DrugBank: Midazolam (DB00683)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01869725
Drug: gallium Ga 68-edotreotide
Normalized name: Gallium Ga 68-edotreotide
DrugBank: Edotreotide gallium Ga-68 (DB15494)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given IV
Study: NCT01143207
Drug: Medroxyprogesterone acetate
Normalized name: Medroxyprogesterone Acetate
DrugBank: Medroxyprogesterone acetate (DB00603)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Injectable hormonal contraceptive
Study: NCT04042233
Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS
Normalized name: vancomycin
DrugBank: Vancomycin (DB00512)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.
Study: NCT04042233
Drug: Standard IV administration of vancomycin
Normalized name: Vancomycin
DrugBank: Vancomycin (DB00512)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: IV antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).
Study: NCT02264678
Drug: Administration of ceralasertib
Normalized name: OIL OF CAMPHOR
DrugBank: Ceralasertib (DB14917)
Approvals — FDA: no, EMA: no, PMDA: no
Description: An oral formulation of ceralasertib will be used. In Module 2 Part A1, patients will receive a single dose of ceralasertib on Day 1, followed by 4 to 6 days washout, before multiple dosing.
Study: NCT02264678
Drug: Administration of ceralasertib in combination with olaparib
Normalized name: Olaparib
DrugBank: Olaparib (DB09074)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: An oral formulations of ceralasertib and olaparib will be used. In Module 2 Part A2, patients will receive either a single or twice daily dose of ceralasertib followed by 4 to 6 days washout, before multiple dosing with ceralasertib and olaparib. In Module 2 Part B, patients will receive ceralasertib and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2. Cycle 0 may be omitted at the discretion of the sponsor.
Study: NCT02264678
Drug: Administation of ceralasertib in combination with durvalumab
DrugBank: Durvalumab (DB11714)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: An oral formulation of ceralasertib will be used. Durvalumab is given via IV infusion. In Module 3 Part A, patients will receive an initial single dose of ceralasertib on Day 1, followed by multiple dosing in combination with durvalumab. In Module 3 Serial Tumour Biopsy Extension and Part B expansion cohorts, patients will receive ceralasertib at the dose, frequency and schedule recommended from Module 3 Part A, in combination with durvalumab.
Study: NCT02264678
Drug: Administration of ceralasertib monotherapy
Normalized name: OIL OF CAMPHOR
DrugBank: Ceralasertib (DB14917)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Module 4 Part A and Module 4 Part B Cohort 3: During C0, patients will receive ceralasertib monotherapy orally once a day on 3 non-consecutive days and ceralasertib twice a day on 5 consecutive days. After the patients have completed C0 (Part A) they may transition to Module 4 Part B cohort 3 where they will continue to receive ceralasertib monotherapy
Study: NCT02264678
Drug: Administration of ceralasertib and olaparib
Normalized name: Olaparib
DrugBank: Olaparib (DB09074)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Module 4 Part B Cohort 1:~After completion of Part A (C0), the patient may transition to Part B and be allocated to receive ceralasertib in combination with olaparib as decided by the investigator.
Study: NCT02264678
Drug: Administration of ceralasertib and durvalumab
DrugBank: Durvalumab (DB11714)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Module 4 Part B Cohort 2:~After completion of Part A (C0), the patient may transition to Part B and be allocated to receive ceralasertib in combination with durvalumab as decided by the investigator.
Study: NCT02264678
Drug: Administration of ceralasertib in combination with AZD5305
Normalized name: COMBINATIONS OF ANTIBACTERIALS
DrugBank: Ceralasertib (DB14917)
Approvals — FDA: no, EMA: no, PMDA: no
Description: An oral formulations of ceralasertib and AZD5305 will be used. In Module 5 Part A, patients will receive a single dose of ceralasertib on cycle 0 Day 1 as per dose level cohort. In Module 5 Part B, patients will receive ceralasertib and AZD5305: C1 onwards (as per dose level cohort allocated).
Study: NCT02963831
Drug: Durvalumab
Normalized name: Durvalumab
DrugBank: Durvalumab (DB11714)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Durvalumab was administered by IV infusion once every four weeks for a total of 10 (Cohort A) or 12 four-week cycles.
Study: NCT02264678
Drug: Administration of ceralasertib in combination with carboplatin
Normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: An oral formulation of ceralasertib will be used. In Module 1 Part A, patients will receive a single dose of ceralasertib on Day 1, followed by multiple dosing in combination with carboplatin. A maximum of 6 cycles (21 days per cycle) of treatment will be given. In Module 1 Part B, patients will receive ceralasertib and carboplatin at the dose, frequency and schedule recommended from Module 1 Part A.