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NCT01475266
Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
Phase 2/Phase 3 trial testing EO9 (Apaziquone) in Bladder Cancer in 51 participants. Terminated before completion.
1 April 2013
Quick facts
| Lead sponsor | Nippon Kayaku Co., Ltd. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 1 November 2011 |
| Primary completion | 1 April 2013 |
| Estimated completion | 1 April 2013 |
| Sites | 20 locations across Japan, South Korea |
Drugs / interventions tested
- EO9 (Apaziquone) — full drug profile →
- Placebo
Conditions studied
- Bladder Cancer — all drugs for Bladder Cancer →
Sponsor
Nippon Kayaku Co., Ltd. — full company profile →
Who can join
20 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
Time frame: 2 years
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Significance of Specific Oxidoreductases in the Design of Hypoxia-Activated Prodrugs and Fluorescent Turn off-on Probes for Hypoxia Imaging.
Janczy-Cempa E, Mazuryk O, Kania A, Brindell M. · · 2022 · cited 25× · PMID 35681666 · DOI 10.3390/cancers14112686 -
New therapeutic targets in the management of urothelial carcinoma of the bladder.
Sverrisson EF, Espiritu PN, Spiess PE. · · 2013 · cited 5× · PMID 24400235 · DOI 10.2147/rru.s29131
Verify or expand the search:
- PubMed search for NCT01475266
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bladder Cancer
Currently open trials in the same condition.
- NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
- NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
- NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
- NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
- NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01475266 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nippon Kayaku Co., Ltd.
- Last refreshed: 27 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01475266.
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