AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT04735926
Drug: Calcifediol 75mcg
RxNorm normalized name: Calcifediol
DrugBank: Calcifediol (DB00146)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Soft gelatin capsule. Oral administration once per week
Trial: NCT04735926
Drug: Calcifediol 100mcg
RxNorm normalized name: Calcifediol
DrugBank: Calcifediol (DB00146)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Soft gelatin capsule. Oral administration once per week
Trial: NCT04735926
Drug: Calcifediol 125mcg
RxNorm normalized name: Calcifediol
DrugBank: Calcifediol (DB00146)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Soft gelatin capsule. Oral administration once per week.
Trial: NCT01120704
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum)
RxNorm normalized name: hydrogen peroxide
DrugBank: Nicotine (DB00184)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IF participant smokes \>10 cigs/day AND is randomized to a 8 week condition: they will be asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants will also be asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.~IF participant smokes 5-10 cigs/day AND is randomized to the 8 week medication condition: they will be asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants will also be asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
Trial: NCT00759525
Drug: Glycyrrhetic Acid
RxNorm normalized name: Glycyrrhetic Acid
DrugBank: Enoxolone (DB13089)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 130 mg daily for fourteen days
Trial: NCT00605891
Drug: carmoterol (CHF 4226)
RxNorm normalized name: CHF-6333
DrugBank: Carmoterol (DB15784)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: carmoterol pMDI 2.0 μg once a day, in the morning~(1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)
Trial: NCT00605891
Drug: carmoterol (CHF 4226)
RxNorm normalized name: CHF-6333
DrugBank: Carmoterol (DB15784)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: carmoterol pMDI 1.0 μg once a day, in the morning~(1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))
Trial: NCT00605891
Drug: carmoterol (CHF 4226)
RxNorm normalized name: CHF-6333
DrugBank: Carmoterol (DB15784)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: carmoterol pMDI 4.0 μg once a day, in the morning~(1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)
Trial: NCT00605891
Drug: salmeterol
RxNorm normalized name: Salmeterol
DrugBank: Salmeterol (DB00938)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)
Trial: NCT00430937
Drug: Daptomycin
RxNorm normalized name: Daptomycin
DrugBank: Daptomycin (DB00080)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 4 mg/kg intravenous once daily
Trial: NCT00430937
Drug: Vancomycin
RxNorm normalized name: Vancomycin
DrugBank: Vancomycin (DB00512)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 1 g intravenous twice daily
Trial: NCT00430937
Drug: Teicoplanin
RxNorm normalized name: teicoplanin
DrugBank: Teicoplanin (DB06149)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.
Trial: NCT04070495
Drug: KW-6356
RxNorm normalized name: KW-7158
DrugBank: KW-6356 (DB17080)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: A single oral dose will be administered at Day 1 and 15
Trial: NCT04070495
Drug: Rifampicin
RxNorm normalized name: Rifampicin
DrugBank: Rifampin (DB01045)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21
Trial: NCT00265018
Drug: Adriamycin
RxNorm normalized name: Adriamycin
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00265018
Drug: Bleomycin
RxNorm normalized name: Bleomycin
DrugBank: Bleomycin (DB00290)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00265018
Drug: Vinblastine
RxNorm normalized name: Vinblastine
DrugBank: Vinblastine (DB00570)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00265018
Drug: DTIC
RxNorm normalized name: DTIC
DrugBank: Dacarbazine (DB00851)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02182271
Drug: BI 201335 ZW - single rising dose
RxNorm normalized name: BI 2536
DrugBank: BI 2536 (DB16107)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03519061
Drug: Budesonide
RxNorm normalized name: Budesonide
DrugBank: Budesonide (DB01222)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Nasal saline irrigations with budesonide
Trial: NCT01252524
Drug: Calcium polycarbophil
RxNorm normalized name: Calcium Polycarbophil
DrugBank: Calcium polycarbophil (DB14684)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: calcium polycarbophil 625 mg po TID before each meal with 8 oz water for 6 months
Trial: NCT04386876
Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Tablet
DrugBank: Ritonavir (DB00503)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey).
Trial: NCT01464528
Drug: Hyaluronan
RxNorm normalized name: hyaluronan
DrugBank: Hyaluronic acid (DB08818)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: single use of 10 mL of the hyalobarrier gel intrauterine immediately following hysteroscopic surgery
Trial: NCT05404516
Drug: Sorafenib
RxNorm normalized name: Sorafenib
DrugBank: Sorafenib (DB00398)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Induction cycle(s): 400 mg BID on days 8-21.~Consolidation cycles 1-4: 400 mg BID on days 1-21.~Maintenance therapy: 400 mg BID for one year.
Trial: NCT05404516
Drug: Idarubicin
RxNorm normalized name: Idarubicin
DrugBank: Idarubicin (DB01177)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Induction cycle(s): 12 mg/m2/day on days 1-3.~Consolidation cycle 1: 8 mg/m2/day administered on days 1-3.
Trial: NCT05404516
Drug: Cytarabine
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Induction cycle(s): 100 mg/m2 by continuous IV infusion for 24 hours on days 1-7.~Consolidation cycles 1-4: 2 g/m2/12h on days 1-3.
Trial: NCT00881075
Drug: SeeMore(TM)
RxNorm normalized name: ethinyl estradiol
DrugBank: Ethinylestradiol (DB00977)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: single dose intravenous injectable
Trial: NCT00003694
Drug: omacetaxine mepesuccinate
RxNorm normalized name: Omacetaxine Mepesuccinate
DrugBank: Omacetaxine mepesuccinate (DB04865)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Given IV
Trial: NCT00003694
Drug: cytarabine
RxNorm normalized name: Cytarabine
DrugBank: Cytarabine (DB00987)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Given IV
Trial: NCT02165111
Drug: Onabotulinumtoxin A
RxNorm normalized name: Onabotulinumtoxina
DrugBank: Botulinum toxin type A (DB00083)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Trial: NCT00330551
Drug: Oral Risperidone
RxNorm normalized name: Risperidone
DrugBank: Risperidone (DB00734)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients will be treated with oral risperidone daily, with the dosage determined by treating psychiatrist.
Trial: NCT00330551
Drug: Risperidone in Long-Acting Injectable Form (Consta)
DrugBank: Risperidone (DB00734)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Participants will take a 25 mg dosage of injectable risperidone (Risperidone in Long-Acting Injectable Form (Consta)) once every 2 weeks. Dosage will be adjusted if needed.
Trial: NCT03697811
Drug: DE-117 Ophthalmic Solution
RxNorm normalized name: DES
DrugBank: Diethylstilbestrol (DB00255)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Trial: NCT02978690
Drug: Spesolimab
RxNorm normalized name: Spesolimab
DrugBank: Spesolimab (DB15626)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Solution for infusion
Trial: NCT01440946
Drug: FIX
RxNorm normalized name: Fixol
DrugBank: Hydroxycitronellal (DB14187)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Vials of prestudy FIX (provided by the participants) were combined as needed, based on the nominal labeled potency (e.g., 250 IU, 500 IU, and 1000 IU), to achieve the participant's calculated dose.
Trial: NCT02233049
Drug: Erlotinib
RxNorm normalized name: Erlotinib
DrugBank: Erlotinib (DB00530)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02233049
Drug: Everolimus
RxNorm normalized name: Everolimus
DrugBank: Everolimus (DB01590)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT02233049
Drug: Dasatinib
RxNorm normalized name: Dasatinib
DrugBank: Dasatinib (DB01254)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01120704
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
RxNorm normalized name: Nicotine
DrugBank: Nicotine (DB00184)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: IF the participant smokes \>10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants will also be asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.~IF the participant smokes 5-10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants will also be asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
Trial: NCT00101101
Drug: Vincristine
RxNorm normalized name: Vincristine
DrugBank: Vincristine (DB00541)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Trial: NCT00101101
Drug: Prednisone
RxNorm normalized name: Prednisone
DrugBank: Prednisone (DB00635)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Trial: NCT00101101
Drug: Dexamethasone
RxNorm normalized name: Dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.
Trial: NCT00101101
Drug: IL-2
RxNorm normalized name: IL-2
DrugBank: Human interleukin-2 (DB14865)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants receive vaccine comprising autologous tumor cells and GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2 as above.
Trial: NCT04519658
Drug: CIN-107
RxNorm normalized name: CIN-QUIN
DrugBank: Quinidine (DB00908)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: CIN-107 tablets by mouth once daily
Trial: NCT02989207
Drug: mitomycin-C
RxNorm normalized name: Mitomycin-C
DrugBank: Mitomycin (DB00305)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: This is an anti scarring agent whcih is an standard adjunctive treatment in glaucoma surgery
Trial: NCT04089267
Drug: TPO
RxNorm normalized name: Tpoxx
DrugBank: Tecovirimat (DB12020)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT03126799
Drug: Erlotinib plus Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks
Trial: NCT03126799
Drug: Erlotinib
RxNorm normalized name: Erlotinib
DrugBank: Erlotinib (DB00530)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Erlotinib 150mg, po, daily, Q weeks
Trial: NCT00499135
Drug: Sunitinib Malate
RxNorm normalized name: Sunitinib Malate
DrugBank: Sunitinib (DB01268)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Given PO
Trial: NCT01934634
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Gemcitabine IV: 1,000 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days
Trial: NCT01934634
Drug: nab-Paclitaxel
RxNorm normalized name: NAB-PACLITAXEL COMPONENT PACLITAXEL
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: nab-paclitaxel IV: 125 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days
Trial: NCT01848990
Drug: Precommercial Hylenex recombinant (hyaluronidase human injection)
RxNorm normalized name: hyaluronidase, human recombinant Injection [Hylenex]
DrugBank: Hyaluronidase (ovine) (DB00070)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT01848990
Drug: Insulin lispro
RxNorm normalized name: Insulin Lispro
DrugBank: Insulin lispro (DB00046)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT01848990
Drug: Insulin aspart
RxNorm normalized name: Insulin Aspart
DrugBank: Insulin aspart (DB01306)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT01848990
Drug: Insulin glulisine
RxNorm normalized name: Insulin Glulisine
DrugBank: Insulin glulisine (DB01309)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01971346
Drug: etanercept
RxNorm normalized name: Etanercept
DrugBank: Etanercept (DB00005)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 100 mg Etanercept injections per week (2 separate single-use pre-filled 50 mg subcutaneous injections taken on two separate days) for 3 months
Trial: NCT03359733
Drug: TAK-659
RxNorm normalized name: TAK-243
DrugBank: TAK-243 (DB15013)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: TAK-659 tablet.
Trial: NCT02199418
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT02199418
Drug: Cisplatin
RxNorm normalized name: Cisplatin
DrugBank: Cisplatin (DB00515)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02136875
Drug: Double dose of Salmeterol + Fluticasone Propionate
RxNorm normalized name: fluticasone propionate / salmeterol Metered Dose Inhaler
DrugBank: Fluticasone propionate (DB00588)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Trial: NCT00360776
Drug: tipifarnib
RxNorm normalized name: Tipifarnib
DrugBank: Tipifarnib (DB04960)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Given orally
Trial: NCT01122511
Drug: 700 ug dexamethasone
DrugBank: Dexamethasone (DB01234)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Intravitreal injection of 700 ug dexamethasone into study eye
Trial: NCT01045304
Drug: Iniparib
RxNorm normalized name: Iniparib
DrugBank: Iniparib (DB13877)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Pharmaceutical form: solution for infusion~Route of administration: intravenous
Trial: NCT01045304
Drug: Gemcitabine
RxNorm normalized name: Gemcitabine
DrugBank: Gemcitabine (DB00441)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Pharmaceutical form: solution for infusion~Route of administration: intravenous
Trial: NCT01045304
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Pharmaceutical form: solution for infusion~Route of administration: intravenous
Trial: NCT00355446
Drug: Bimatoprost 0.03%
RxNorm normalized name: BIMATOPROST 0.03% SOLN,OPH
DrugBank: Bimatoprost (DB00905)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Trial: NCT01037478
Drug: Resminostat (4SC-201)
RxNorm normalized name: resminostat
DrugBank: Resminostat (DB12392)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral administration
Trial: NCT00462956
Drug: Tykerb
RxNorm normalized name: Tykerb
DrugBank: Lapatinib (DB01259)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: lapatinib 1500mg daily
Trial: NCT01205724
Drug: turoctocog alfa pegol
RxNorm normalized name: Turoctocog alfa pegol
DrugBank: Turoctocog alfa pegol (DB14738)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: Single dose (low) administered intravenously (into the vein)
Trial: NCT01205724
Drug: turoctocog alfa pegol
RxNorm normalized name: Turoctocog alfa pegol
DrugBank: Turoctocog alfa pegol (DB14738)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: Single dose (medium) administered intravenously (into the vein)
Trial: NCT01205724
Drug: turoctocog alfa pegol
RxNorm normalized name: Turoctocog alfa pegol
DrugBank: Turoctocog alfa pegol (DB14738)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: Single dose (high) administered intravenously (into the vein)
Trial: NCT02423265
Drug: Ranolazine
RxNorm normalized name: Ranolazine
DrugBank: Ranolazine (DB00243)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Ranolazine: 500 mg twice day, up-titrated after 1 week to 1000 mg twice a day
Trial: NCT00700011
Drug: Clofarabine
RxNorm normalized name: Clofarabine
DrugBank: Clofarabine (DB00631)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 10 mg/m2 x 5 days per 4 to 6 week cycles
Trial: NCT00700011
Drug: Clofarabine
RxNorm normalized name: Clofarabine
DrugBank: Clofarabine (DB00631)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 5 mg/m2 x 5 days per 4 to 6 week cycles
Trial: NCT02147808
Drug: Telotristat etiprate
RxNorm normalized name: Telotristat etiprate
DrugBank: Telotristat (DB14218)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: All subjects will receive two 250 mg telotristat etiprate tablets three times daily.
Trial: NCT02147808
Drug: Midazolam
RxNorm normalized name: Midazolam
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: All subjects will receive 3 mg (1.5 mL oral syrup \[2mg/mL\]).
Trial: NCT00296556
Drug: Rivenprost (drug)
RxNorm normalized name: Rivenprost
DrugBank: Rivenprost (DB16315)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00917813
Drug: KD-247
RxNorm normalized name: POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)
DrugBank: Poly(lactic acid) (DB15037)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Cohort 1 - 4 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 2 - 8 mg/kg KD-247 IV on Days 1, 8, and 15; Cohort 3 - 16 mg/kg KD-247 IV on Days 1, 8, and 15
Trial: NCT00228527
Drug: Esomeprazole (Nexium)
RxNorm normalized name: esomeprazole Injection [Nexium]
DrugBank: Esomeprazole (DB00736)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02379585
Drug: paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20
Trial: NCT02379585
Drug: docetaxel
RxNorm normalized name: Docetaxel
DrugBank: Docetaxel (DB01248)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: For patients with HER2 positive breast cancer: docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
Trial: NCT02379585
Drug: Trastuzumab
RxNorm normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
Trial: NCT02379585
Drug: Pertuzumab
RxNorm normalized name: Pertuzumab
DrugBank: Pertuzumab (DB06366)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
Trial: NCT01578551
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 200 mg/m² IV over 3 hours, day 1 of each cycle. Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy.