Clinical Trials Directory

Trials / Completed

CompletedNCT03081858

Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer

A Phase 1/2a Pilot Study of Intravesical TSD-001 for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Lipac Oncology LLC · Industry
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGTSD-001Administered via intravesical instillation.

Timeline

Start date
2018-05-17
Primary completion
2020-08-27
Completion
2021-08-05
First posted
2017-03-16
Last updated
2025-06-27
Results posted
2025-06-13

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03081858. Inclusion in this directory is not an endorsement.