Trial Title:
Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
NCT ID:
NCT05704244
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FE 999326
Description:
75 mL FE 999326 (3 x 10^11 vp/mL) of sterile suspension instilled once every 3 months
into the bladder via a urinary catheter
Arm group label:
FE 999326
Other name:
nadofaragene firadenovec
Summary:
To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade,
BCG unresponsive NMIBC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have at entry, confirmed by a pathology report:
1. Carcinoma in situ (CIS) only
2. Ta/T1 high-grade disease with concomitant CIS or
3. Ta/T1 high-grade disease without concomitant CIS
- Subjects who did not respond to BCG treatment and have a persistent high-grade
recurrence within 12 months after BCG was initiated, and those who despite an
initial complete response to BCG, relapse with CIS within 12 months of their last
intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6
months of their last intravesical treatment with BCG.
- Life expectancy >2 years, in the opinion of the investigator
- Eastern Cooperative Oncology Group (ECOG) status 2 or less
- Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma
within the prostatic urethra
- Subjects with prostate cancer on active surveillance at low risk for progression,
defined as prostate-specific antigen (PSA) <10 ng/dL
Exclusion Criteria:
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic
disease presented at the screening visit.
- Current systemic therapy for bladder cancer
- Current or prior investigational treatment for BCG unresponsive NMIBC or any other
investigational drug within 1 month prior to screening
- Current or prior pelvic external beam radiotherapy within 5 years of entry
- Use of other adenovirus vector medications, including COVID-19 vaccines, within 2
weeks before and after instillation
- History of malignancy of other organ system within past 5 years, except treated
basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract
urothelial carcinoma at least 24 months after nephroureterectomy.
- Subjects who cannot hold instillation for 1 hour
- Subjects who cannot tolerate intravesical dosing or intravesical surgical
manipulation
- Intravesical therapy within 8 weeks prior to beginning trial treatment, with the
exception of:
- Cytotoxic agents when administered as a single instillation immediately
following a TURBT procedure
- Previous intravesical BCG therapy
- Systemic immunosuppressive therapy within 3 months prior to screening
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ferring Investigational Site
Address:
City:
Nagakute-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Nagoya-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Narita-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Matsuyama-Shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Fukuoka-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Hiroshima-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Hakodate-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Sapporo-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Hitachi-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Tsukuba-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Kawasaki-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Yokohama-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Nankoku-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Tsu-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Sendai-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Matsumoto-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Kashihara-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Okayama-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Takatsuki-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Bunkyo-ku
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Minato-ku
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Mitaka-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Toyama-shi
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ferring Investigational Site
Address:
City:
Wakayama-shi
Country:
Japan
Status:
Recruiting
Start date:
December 21, 2022
Completion date:
December 27, 2029
Lead sponsor:
Agency:
Ferring Pharmaceuticals
Agency class:
Industry
Source:
Ferring Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704244
