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Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
NCT03081858 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03081858
The ClinicalTrials.gov registry entry for NCT03081858 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lipac Oncology, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03081858 reports 5 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Urinary Bladder Neoplasms, Urologic Diseases, Urogenital Neoplasms, Urologic Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03081858?
The interventions under investigation include: TSD-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03081858?
This trial is sponsored by Lipac Oncology, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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