Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia

Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.

Start Date28 Aug 2016

Sponsor / Collaborator

IOMEDICO AG

[+1]

NL-OMON47296 / CompletedNot Applicable

A phase 1 dose escalation and cohort expansion study of ERY974, an anti-Glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumor - Chugai101EG

Start Date12 Aug 2016

Sponsor / Collaborator

Chugai Pharma Europe Ltd.

NCT02251860 / CompletedNot Applicable

A Prospective, Non-Interventional Study in Germany to Evaluate the Long-Term Effectiveness and Tolerability of Subcutaneously Administered RoActemra® (Tocilizumab; TCZ) in Patients With Rheumatoid Arthritis in Daily Clinical Practice (as Recommended in Label)

ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Participants will be followed over an observation period of up to 2 years after the initial injection.

Start Date20 May 2014

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

[+1]

100 Clinical Results associated with Chugai Pharma Europe Ltd.

0 Patents (Medical) associated with Chugai Pharma Europe Ltd.

Literatures (Medical) associated with Chugai Pharma Europe Ltd.

01 May 2020·The Lancet NeurologyQ1 · MEDICINE

Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial

Q1 · MEDICINE

Article

Author: Greenberg, Benjamin M ; Weinshenker, Brian G ; Wright, Padraig ; Bennett, Jeffrey L ; Szczechowski, Lech ; Fox, Edward ; Kawata, Yuichi ; Garren, Hideki ; Shkrobot, Svitlana ; Gianella-Borradori, Athos ; Terada, Yusuke ; Yamamura, Takashi ; Traboulsee, Anthony

BACKGROUNDSatralizumab, a humanised monoclonal antibody targeting the interleukin-6 receptor, reduced the risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD) when added to immunosuppressant therapy. This study assessed the safety and efficacy of satralizumab monotherapy in patients with the disorder.METHODSIn this phase 3, double-blind, placebo-controlled, parallel-group trial, we enrolled adults aged 18-74 years with aquaporin-4 antibody seropositive or seronegative NMOSD at 44 investigational sites in 13 countries. Eligible participants had experienced at least one documented NMOSD attack or relapse in the past 12 months and had a score of 6·5 or less on the Expanded Disability Status Scale. Exclusion criteria included clinical relapse 30 days or fewer before baseline. Participants were randomly assigned (2:1) to receive satralizumab 120 mg or visually matched placebo subcutaneously at weeks 0, 2, 4, and every 4 weeks thereafter. Taking immunosuppressants concomitantly was prohibited. The primary endpoint was time to the first protocol-defined relapse, based on the intention-to-treat population and analysed with stratification for two randomisation factors (previous therapy for prevention of attacks and nature of the most recent attack). Safety was assessed in all participants who received at least one dose of satralizumab or placebo. The double-blind phase was due to last until 44 protocol-defined relapses occurred or 1·5 years after random assignment of the last patient enrolled, whichever occurred first; participants could enter an open-label phase after the occurrence of a protocol-defined relapse or at the end of the double-blind phase. The study is registered with ClinicalTrials.gov, NCT02073279.FINDINGS95 (57%) of 168 screened participants were randomly assigned to treatment (63 to satralizumab; 32 to placebo) between Aug 5, 2014, and April 2, 2017. Protocol-defined relapses occurred in 19 (30%) patients receiving satralizumab and 16 (50%) receiving placebo (hazard ratio 0·45, 95% CI 0·23-0·89; p=0·018). 473·9 adverse events per 100 patient-years occurred in the satralizumab group, as did 495·2 per 100 patient-years in the placebo group; the incidence of serious adverse events and adverse events leading to withdrawal was similar between groups.INTERPRETATIONSatralizumab monotherapy reduced the rate of NMOSD relapse compared with placebo in the overall trial population, with a favourable safety profile. The patient population included a ratio of aquaporin-4 antibody seropositive and seronegative patients that was reflective of clinical practice. Satralizumab has the potential to become a valuable treatment option for patients with NMOSD.FUNDINGChugai Pharmaceutical (Roche).

01 Apr 2019·Drug Discovery TodayQ2 · MEDICINE

Promotion of Japan’s participation in global clinical trials

Q2 · MEDICINE

Article

Author: Shimada, Yasuteru ; Ozawa, Takatoshi ; Kondo, Hideyuki

The number of global clinical trials including Japan is increasing but still much lower than those including the USA and Europe. The regulatory requirements for clinical trials have been harmonized among Japan, USA, and Europe, and the quality of clinical trials is kept high in these regions. Xofluza (baloxavir marboxil) for influenza approved in Japan under the SAKIGAKE Designation System is a good example of clinical trials including Japan. To include Japan in more global clinical trials, stakeholders should work more collaboratively, and increase the perception that clinical trials can be conducted appropriately and efficiently in Japan. Further measures for better management of clinical trials should also be developed. These would ultimately lead to improved benefits for patients with timely access to new drugs.

20 May 2017·Journal of Clinical Oncology

A phase I dose escalation (DE) and cohort expansion (CE) study of ERY974, an anti-glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumors.

Author: Gianella-Borradori, Athos ; Shimada, Sumire ; Ishiguro, Takahiro ; Kaneko, Akihisa ; Hashimoto, Kenji ; Ueda, Masamichi ; Komatsu, Shun-ichiro ; Sugaya, Naofumi ; Matsushima, Junnosuke ; Ogita, Yoshitaka ; Sano, Yuji ; Kishishita, Shohei ; Nakamura, Mikiko ; Frings, Werner ; Rossi, Sheila ; Perera, Ayesh

TPS3112 Background: Bispecific antibodies to facilitate T-cell directed cytotoxicity (TDCC) is a proven therapy strategy in cancer. ERY974 is a humanized IgG4 bispecific antibody designed to simultaneously bind to cytotoxic T-cell CD3 receptors and GPC3 (a glycoprotein expressed on cell surface of several tumors) to elicit T-cell activation and TDCC. The objectives of this multi-country, phase 1 study of ERY974 is to determine the maximum tolerated dose (MTD) and to perform a preliminary assessment of anti-tumor activity in patients with solid tumors expressing GPC3. Methods: ERY974 is dosed IV weekly. All patients receive premedication with dexamethasone (DEX) prior to 1st and 2nd ERY974 dose. DE uses an accelerated titration design (ATD), then a modified continual reassessment method (mCRM) described by one-parameter logistic model, to determine MTD, where DLT occurrence rate is 0.25. Combining ATD and mCRM is to permit rapid dose escalation whilst minimizing patient numbers exposed to sub-therapeutic doses, and to accurately determine MTD. Once grade 2 (G2) cytokine release syndrome (CRS) is observed, DEX is increased. If ≥G2 CRS is again observed, then at all subsequent doses the 1st dose of ERY974 is fixed at the last dose level when < G2 CRS was not seen, DE proceeds with the 2nd dose. ATD commences with n = 1, increasing to n = 3 once drug-related ≥G2 toxicity is seen. mCRM starts after 1st dose limiting toxicity (DLT), with the modifications of at least 3 patients required to dose escalate and up to 1.5x increment to minimize risk of toxicity. CE has 3 arms: GPC3+ gastric/gastroesophageal junction adenocarcinoma; GPC3+ squamous esophageal cancer; and other GPC3+ tumors. A 2-stage design is used to allow CE to stop early for futility. Subjects are adults with histologically confirmed, measurable malignant solid tumors and/or metastatic disease not amenable to standard therapy, and life expectancy ≥3 months. Patients with > 1cm or > 1 brain metastasis, current/previous interstitial lung disease, and acute/chronic infection are excluded. 3 cohorts have been completed without DLT. Cohort 4 began in January 2017. Clinical trial information: NCT02748837.

100 Deals associated with Chugai Pharma Europe Ltd.

100 Translational Medicine associated with Chugai Pharma Europe Ltd.

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