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進行性または体の他の部位に転移した膵臓がん患者を対象としたLY2157299の臨床試験

完了NCT02154646第1相

The main purpose of this study is to evaluate the safety and side effects of LY2157299 in combination with gemcitabine in Japanese participants with pancreatic cancer that is advanced or has spread to another part of the body.

対象疾患:
Pancreatic Neoplasms

切除可能境界膵癌に対する術前FIRINOX療法-パイロット研究

完了NCT02148549第1相

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen

対象疾患:
Patients With Borderline Resectable Pancreatic Cancer

全身性エリテマトーデスにおけるアタシセプトの有効性と安全性

完了NCT01972568第2相

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

対象疾患:
Lupus Erythematosus, Systemic

アジア人患者を対象とした経口BGJ398の第I相試験

完了NCT01697605第1相

This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

対象疾患:
Tumor With Alterations of the FGF-R

下痢優位型過敏性腸症候群(IBS)の女性患者におけるYM060の有効性および安全性を評価するための研究

完了NCT01870895第3相

To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

対象疾患:
Diarrhea-predominant Irritable Bowel Syndrome

前方切除術における下腸間膜動脈の高位結紮と低位結紮を評価するための無作為化比較試験

不明NCT01861678第3相

The tying at a radix of the inferior mesenteric artery (IMA) is recognized as radical cure technique in a rectal cancer surgery in Japan. In one side, the preserving the left colic artery (LCA) that is the technique to maintain blood flow of proximal sigmoid colon is performed in practice. However, there is no evidence that shows effectiveness of this technique. We conducted a randomized trial that compared between high tie and low tie of the IMA in rectal anterior resection to define an appropriate portion of IMA tying.

対象疾患:
Colon Rectal ResectionRectal Cancer

加齢黄斑変性症に対する必要時投与および2ヶ月ごとの硝子体内アフリベルセプト投与に関する研究

完了NCT01824225第4相

Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration.

対象疾患:
Age-related Macular Degeneration

クリゾチニブ未治療のALK活性化非小細胞肺癌成人患者におけるLDK378の有効性

完了NCT01685138第2相

A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was continued beyond RECIST defined progressive disease (PD) as assessed by the investigator, if in the judgment of the investigator, there was evidence of clinical benefit. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).

対象疾患:
Non-Small Cell Lung Cancer

プラチナ製剤による前治療歴のある再発性または転移性頭頸部癌患者における、ブパルリシブ(BKM120)+パクリタキセルとプラセボ+パクリタキセルの有効性および安全性の比較研究

中止NCT01852292第2相

Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.

対象疾患:
Head and Neck Squamous Cell Carcinoma

健康な日本人成人被験者を対象としたTMC278の単回投与薬物動態および安全性試験

完了NCT01804244第4相

The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed conditions in healthy Japanese adult male participants.

対象疾患:
Healthy

帝王切開時に少量のブドウ糖を投与した場合の効果

不明NCT01706341該当なし

The purpose of this study is to investigate the effect of administering a small dose of glucose on the pregnant women and their neonates during cesarean section. We investigate the safety and efficacy of use of a glucose-containing solution for the pregnant women and the neonates.

対象疾患:
Cesarean Section

RAS変異型肝細胞癌(HCC)に対するレファメチニブとソラフェニブの併用療法

完了NCT01915602第2相

This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement \[modified response evaluation criteria in solid tumors (mRECIST)\] assessed by external independent radiologists. Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.

対象疾患:
Carcinoma, Hepatocellular

高度近視眼における近視性牽引性黄斑症に対する硝子体切除術の外科的治療成績

完了NCT01658761該当なし

Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.

対象疾患:
High MyopiaMaculopathySurgery

乳がん患者を対象としたNK105の第III相臨床試験

完了NCT01644890第3相

To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.

対象疾患:
Breast Cancer Nos Metastatic Recurrent

HER2陰性転移性乳がん患者の一次治療として、パクリタキセルとベバシズマブの併用療法および関連バイオマーカーの有効性および安全性を、パクリタキセルとプラセボの併用療法と比較して評価する研究

完了NCT01663727第3相

This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.

対象疾患:
Metastatic Breast Cancer

インスリンMix25とMix50の比較

完了NCT01773473第4相

The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25 (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with Type 2 diabetes mellitus (T2DM).

対象疾患:
Type 2 Diabetes Mellitus

RAS変異型肝細胞癌(HCC)に対するレファメチニブ(BAY86-9766)

完了NCT01915589第2相

This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.

対象疾患:
Carcinoma, Hepatocellular

CML(慢性骨髄性白血病)患者におけるニロチニブ無治療寛解試験

完了NCT01784068第2相

The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment

対象疾患:
Chronic Myelogenous Leukemia

放射線療法誘発性悪心・嘔吐(RINV)に対するSyB D-0701の第II相臨床試験

完了NCT01700140第2相

The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.

対象疾患:
Radiotherapy-induced Nausea and Vomiting (RINV)

小児心疾患における心臓バイオマーカー

完了NCT01834976

The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.

対象疾患:
Congenital Heart Disease