Nagoya-shi, Japan
The Real-world Treatment Satisfaction by Gefapixiant in RCC
Chronic cough has a high global prevalence, but appears to be poorly recognized. Most patients respond to specific treatments against causes of chronic cough. Meanwhile, cough is refractory to such treatments by approximately 20% of patients and they are regarded as "refractory chronic cough (RCC). Gafapixant is a P2X3 receptor antagonist that has demonstrated the reduction of cough in patients with RCC through the inhibition of ATP transmission to afferent nerves. According to the COUGH-1 and COUGH-2, taste disturbance is the most frequent adverse event by gefapixant, with the incidence of 59.3% in COUGH-1 and 68.9% in COUGH-2, respectively. Although 45 mg of gefapixant is well-tolerated even if taste disturbance has occurred, the impact of taste disturbance on cough-specific QoL remains to be unclear in RCC and UCC. Furthermore, both taste disturbance and the improvement of cough by gefapixant would be associated with treatment satisfaction. Therefore, the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in RCC patients. The investigator hypothesize that taste disturbance will be associated with the improvement of cough specific QoL and treatment satisfaction in RCC patients. Furthermore, the investigator would like to evaluate the association of taste disturbance with cough-specific QoL in the real-world clinical practice. In addition, there are no biomarkers available that can predict the efficacy of the improvement of cough by gefapixant. The investigator will also explore biomarkers that can be helpful in predicting well response to gefapixant in RCC and UCC patients.
Phase
N/ASpan
82 weeksSponsor
Nagoya City UniversityNagoya, Aichi
Recruiting
Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
This randomized phase II trial targets early-stage breast cancer (stage II-III) with preoperative chemotherapy (NAC). It compares standard treatment with multiple experimental treatments using an adaptive design, allowing new treatments to be added during or after the trial. Patients are classified by subtype and randomized between standard and experimental treatments. The trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor DNA (ctDNA) evaluation for precise efficacy and prognosis prediction.
Phase
2Span
836 weeksSponsor
Nagoya City UniversityNagoya, Aichi
Recruiting
A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis
Phase
2Span
45 weeksSponsor
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyNagoya, Aichi
Recruiting
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
Phase
2Span
110 weeksSponsor
Eli Lilly and CompanyNagoya, Aichi
Recruiting
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Phase
1Span
163 weeksSponsor
Eli Lilly and CompanyNagoya, Aichi
Recruiting
A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)
Phase
3Span
386 weeksSponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyNagoya, Aichi
Recruiting
Phase 3 Efficacy and Safety Study of GTX-102 in Pediatric Subjects with AS
Phase
3Span
156 weeksSponsor
Ultragenyx Pharmaceutical IncNagoya
Recruiting
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Phase
3Span
308 weeksSponsor
Gilead SciencesNagoya
Recruiting
A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients
This is a multi-center, open label Phase 2 study designed to evaluate safety and tolerability and confirm efficacy by BICR of avutometinib in combination with defactinib in Japanese patients with molecularly profiled recurrent LGSOC.
Phase
2Span
157 weeksSponsor
Verastem, Inc.Nagoya, Aichi
Recruiting
Utility of Adjusting Chemotherapy Dose & Dosing Schedule with the SALVage Weekly Dose-dense Regimen in Patients with Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
SALVOVAR is a pragmatic open-label multicenter randomized phase III trial (ratio 1:1) comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the same standard regimen as given during neo-adjuvant period. The randomization will be stratified on the main clinical prognostic factors assumed to impact the efficacy of the assessed arms and the overall survival: 1. Bevacizumab: planned administration: Yes, vs No 2. BRCA mutation: planned administration: Yes, vs No/Unknown 3. KELIMTM strate within unfavorable KELIM subgroup: very unfavorable < 0.7, vs moderately unfavorable [0.7-1.0[ The trial will be pragmatic, as it aims at confirming the superiority of the adjusted chemotherapy compared to the continuation of the standard chemotherapy in routine clinical practice, in a population of ovarian cancer patients close to the real-life clinical activity with few selection criteria.
Phase
3Span
204 weeksSponsor
ARCAGY/ GINECO GROUPNagoya
Recruiting