A multicenter, open-label, phase 2 study of S-588410 as a single maintenance therapy after a first treatment with platinum-containing chemotherapy agents in patients with advanced cancer of the bladder and/or bladder cancer that has spread to other areas of the body.
- Conditions
- Advanced and/or metastatic bladder cancer, which is under control according to first-line chemotherapy.MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005274-22-GB
- Lead Sponsor
- Shionogi & Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 81
? Patients with advanced and/or metastatic bladder cancer (including urothelial cancer of renal pelvis, ureters, and urethra) who have complete response (CR), partial response (PR), or stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at the end of at least 4 cycles of firstline platinum-containing systemic chemotherapy.Common Terminology Criteria for Adverse Events [CTCAE] version 4.03.)
? Patients who are male or female aged =20 years at the time of informed consent.
? Patients with the ECOG PS 0 or 1 at enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42
? Patients who have progressive disease (PD) on RECIST version 1.1 at the end of at least 4 cycles of first-line platinum-containing chemotherapy.
? Patients who are judged to have clinically progressive symptoms at the end of at least 4 cycles of first-line platinum-containing chemotherapy by the investigator or subinvestigator.
? Patients with a history of malignant cancer (except for carcinoma in situ or intra-mucosal cancer that resolved with endoscopic therapy) within 5 years before enrollment.
? Patients who received any prior therapies for target disease within 3 weeks before the first administration of S-588410.
? Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment.
– Anti-malignant tumor drug
– Systemic corticosteroid (except for corticosteroid defined as the equivalent of prednisone = 10 mg/day orally)
– Systemic immunosuppressant drug
– Immunotherapy
– Radiotherapy (except for restricted radiotherapy for pain relief of bone metastasis) for the target disease
– Surgical therapy for the target disease
– Hyperthermia for the target disease
– Herbal medicine with anti-tumor or immunosuppressant effect
– Other investigational new products
? Patients who have severe (CTCAE version 4.03 grade 3 or higher) concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease, with the exception of any symptoms and/or signs associated with target disease.
? Patients who have the following laboratory data with grade 3 or higher according to CTCAE version 4.03 criteria within 28 days before enrollment.
– White blood cell count <2000/mm3 or >100 000/mm3
– Platelet count <50 000/mm3
– Hemoglobin <8.0 g/dL
– Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5.0 × the upper limit of normal (ULN)
– Total bilirubin >3.0 × ULN
– Serum creatinine >3.0 × ULN
? Patients who have known human immunodeficiency virus infection.
? Patients with uncontrolled systemic or active infection.
? Patients who had any diseases with the risk of sudden death within 12 months before enrollment.
[Examples]
– Myocardial infarction
– Unstable angina
– Coronary or peripheral artery bypass graft surgery
– Thrombotic or embolic events such as pulmonary embolism, deep vein thrombosis, or transient ischemic attack
? Patients who have known brain metastases.
? Patients with a history or evidence of autoimmune diseases and/or immunodeficiency disorders.
? Patients with a history of severe (CTCAE version 4.03 grade 3 or higher) allergic reaction to a drug, vaccination, or biological preparation.
? Female patients who are lactating or pregnant. Female patients who are of childbearing potential, not included in any of the following, are positive for the pregnancy test at enrollment.
– Postmenopausal woman (at least 2 years since their last regular menstrual pe
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method