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NCT03081858 · ClinicalTrials.gov registry record · Phase 1
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
A Phase 1 study of Bladder Cancer and Non-muscle Invasive Bladder Cancer, sponsored by Lipac Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 5
- Study locations
NCT03081858: Completed Phase 1 study of Bladder Cancer and Non-muscle Invasive Bladder Cancer, sponsored by Lipac Oncology.
NCT03081858 is a Phase 1 study of Bladder Cancer and Non-muscle Invasive Bladder Cancer that has completed, run by Lipac Oncology. The registered enrollment target is 15 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03081858, a Phase 1 study of Bladder Cancer and Non-muscle Invasive Bladder Cancer, has completed, sponsored by Lipac Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder. Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established). Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (uni-or multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest nontoxic dose (i.e., MTD) established in part 1 of the study. May meet definition of low grade without histological tissue diagnosis if on cystoscopic assessment they have a solitary papillary tumor. Part 3 of the study will continue to track subjects enrolled in Parts 1 and 2 to determine rates of disease-free survival.
Primary Outcome
Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.
Conditions Studied
Interventions
- DRUG TSD-001
Study Locations (5)
California
- Trovare Clinical Research - Bakersfield
- Tower Urology - Los Angeles
Arizona
- Urological Associates of Southern Arizona, PC - Tucson
Maryland
- Chesapeake Urology Associates - Hanover
South Carolina
- Carolina Urologic Research Clinic - Myrtle Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-05-17 |
| Est. Completion | 2021-08-05 |
| Phase | Phase 1 |
What the finished NCT03081858 record still lists
NCT03081858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 10 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which TSD-001 is the first listed.
NCT03081858 lists 5 locations in 4 states (California, Arizona, Maryland).
Frequently Asked Questions
What is clinical trial NCT03081858 about?
NCT03081858 is a clinical study titled "Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer". This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder. Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive...
What is the current status of trial NCT03081858?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-05-17. Estimated completion is 2021-08-05.
What conditions does trial NCT03081858 study?
This clinical trial studies the following conditions: Bladder Cancer, Non-muscle Invasive Bladder Cancer, Urinary Bladder Neoplasms, Urologic Diseases, Urogenital Neoplasms.
What interventions are being tested in trial NCT03081858?
The interventions under investigation include: TSD-001 (DRUG).
Who is sponsoring clinical trial NCT03081858?
This trial is sponsored by Lipac Oncology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03081858 being conducted?
This trial has 5 study locations across Arizona, California, Maryland, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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