ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
Recruiting
Phase 3
Interventional Study
Transitional Cell Cancer of Renal Pelvis and Ureter
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Steba Biotech S.A. · Other
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About This Trial
This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male and female patients 18 years or older
* Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
* New or recurrent low-grade, non-invasive UTUC disease
* Biopsy-proven disease . A concurrence of…
Contacts