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リーダーズ・フリー・ジャパン

不明NCT02348021第3相

Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years.

対象疾患:
Coronary Disease

プレガバリンで治療された、下肢痛(神経障害性成分)を伴う慢性腰痛患者におけるPRO

完了NCT02273908

The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

対象疾患:
Low-Back Pain

不眠症患者におけるエスゾピクロンの安全性および有効性の調査

完了NCT02452684

To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.

対象疾患:
Insomnia

20歳以上の成人被験者におけるASP7374の安全性評価試験

完了NCT02366962第3相

The purpose of this study is to confirm the safety until Day 29 after injection of a single dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older

対象疾患:
InfluenzaVaccine

統合失調症患者におけるDSP-5423Pの長期研究

完了NCT02335658第3相

The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.

対象疾患:
Schizophrenia

転移性または切除不能膀胱癌患者を対象としたニボルマブの研究

完了NCT02387996第2相

The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.

対象疾患:
Various Advanced Cancer

頭頸部がん患者におけるMEDI4736単剤療法およびトレメリムマブとの併用療法と標準治療との比較研究

完了NCT02369874第3相

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.

対象疾患:
Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN

CAR-T長期追跡(LTFU)研究

募集中NCT02445222第3相

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

対象疾患:
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

再発性/転移性頭頸部癌患者を対象とした、MEDI 4736(トレメリムマブ併用/非併用)と標準治療(SOC)との比較に関する第III相非盲検試験

完了NCT02551159第3相

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

対象疾患:
Squamous Cell Carcinoma of the Head and Neck

進行がんを患う日本人参加者を対象としたLY3023414の研究

完了NCT02536586第1相

The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity.

対象疾患:
Neoplasm

非小細胞肺癌に対する併用化学療法における制吐剤の有効性を評価する研究

完了NCT02364804

The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).

対象疾患:
Non-small Cell Lung Cancer

AZD0585の第III相長期臨床試験(日本)

完了NCT02463071第3相

This study is a randomised, double-blind phase III long-term study to evaluate efficacy and safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients with hyperlipidemia accompanied by hypertriglyceridemia .

対象疾患:
Hypertriglyceridemia

全身性エリテマトーデス治療のための生物学的製剤の安全性および有効性に関する研究

完了NCT02265744第2相

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

対象疾患:
Lupus

転移性または進行性非扁平上皮非小細胞肺癌(NSCLC)の成人患者で、現在または過去に喫煙歴のある患者を対象に、ベリパリブ+カルボプラチン+パクリタキセル療法と治験責任医師が選択した標準化学療法との比較試験

完了NCT02264990第3相

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.

対象疾患:
Non-squamous Non-small Cell Lung Cancer

転移性または局所進行性固形腫瘍におけるMSB0011359C(M7824)

完了NCT02517398第1相

The main purpose of this Phase I study was to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

対象疾患:
Solid Tumors

メトトレキサート療法にもかかわらず活動性関節リウマチを有する被験者におけるLBEC0101とエンブレル®の比較研究

不明NCT02357069第3相

This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.

対象疾患:
Arthritis, Rheumatoid

慢性便秘(CC)患者を対象としたKWA-0711の第II相用量探索試験

完了NCT02281630第2相

The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.

対象疾患:
Chronic Constipation

EGFRチロシンキナーゼ阻害剤(TKI)に対する耐性を獲得した上皮成長因子受容体(EGFR)活性化変異陽性(EGFRm+)進行非小細胞肺癌(NSCLC)患者における、エルロチニブとの併用によるASP2215の研究

中止NCT02495233第1/第2相

The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.

対象疾患:
Non-Small-Cell Lung Cancer

非小細胞肺がんにおけるアベルマブ(JAVELIN Lung 200)

完了NCT02395172第3相

The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.

対象疾患:
Carcinoma, Non-Small-Cell Lung

EGFR野生型(wt)進行非小細胞肺癌(NSCLC)患者における経口cMET阻害剤INC280の研究(ジオメトリーモノ-1)

完了NCT02414139第2相

Study to evaluate the efficacy and safety of capmatinib as a single-agent treatment for subjects with advanced/metastatic (stage IIIB or IV) non-small cell lung cancer (NSCLC) who had wild-type epidermal growth factor receptor (EGFR wt) (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK)-negative rearrangement, and mesenchymal epithelial transition (MET) mutations leading to exon 14 deletion (referred to as MET mutation hereafter) and/or MET amplification.

対象疾患:
Carcinoma, Non-Small-Cell Lung