Jyoetsu,niigata, Japan
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 GROUPKoshigaya
Recruiting
Koshigaya, Saitama
Recruiting
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Total duration of study will be up to 6 years 6 months.
Phase
3Span
364 weeksSponsor
Janssen Research & Development, LLCKoshigaya
Recruiting
Koshigaya, Saitama
Recruiting
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Phase
2Span
322 weeksSponsor
Janssen Research & Development, LLCKoshigaya
Recruiting
Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)
This is a prospective, multi center, multinational, non-interventional observational study. All patients will be managed according to the clinical site's normal clinical practice, i.e., the diagnostic and clinical treatment/practice process that a clinician chooses according to their clinical judgement for an SMA patient. Clinical care will not be driven by the protocol. No additional visits or investigations will be performed beyond normal clinical practice. Patients will be followed for 15 years from enrolment or until death, whichever is sooner.
Phase
N/ASpan
1032 weeksSponsor
Novartis PharmaceuticalsKoshigaya, Saitama
Recruiting
Product Surveillance Registry
Phase
N/ASpan
1466 weeksSponsor
MedtronicKoshigaya, Saitama
Recruiting
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Phase
3Span
140 weeksSponsor
ModernaTX, Inc.Koshigaya, Saitama
Recruiting
Healthy Volunteers
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
Phase
N/ASpan
3027 weeksSponsor
MedtronicKoshigaya
Recruiting
Koshigaya, Saitama
Recruiting