Phase 2
N=15
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
Bladder Cancer Cell Transitional · Non-Muscle Invasive Bladder Cancer · Bladder Cancer · Urinary Bladder · Transitional Cell Carcinoma of the Bladder
Bottom Line
View on ClinicalTrials.gov: NCT03081858 ↗Enrolled (actual)
15
Serious AEs
8.0%
Results posted
Jun 2025
Primary outcome: Primary: Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD) — NA; 360 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TSD-001 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lipac Oncology LLC
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD) |
NA; 360 | — |
| PRIMARY Part 2: Marker Lesion Response Rate |
0; 1; 3; 1; 3; 2 | — |
| SECONDARY Part 1: Determine Paclitaxel Concentrations |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Part 2: Determine Paclitaxel Concentrations |
0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of low grade (G1 or G2), uni- or multifocal papillary appearing bladder tumor, stage Ta.
- For part 1, subject will have ≥ 1 and ≤ 5 tumors (prior to TURBT), none of which exceeds 3.0 cm in diameter; for part 2, patient will have ≥ 2 and ≤ 5 tumors (prior to TURBT), none of which exceeds 3.0 cm in diameter (resection loop ~1 cm), OR, for part 2, subject meets this inclusion if on cystoscopic assessment they have a solitary papillary tumor (> 0.5 cm and ≤ 2.0 cm in diameter)..
- Subject is surgical candidate for TURBT as part of normal NMIBC treatment plan. For part 1, successful completion of TURBT procedure. For part 2, successful completion of cystoscopic assessment/TURBT procedure with one marker lesion left intact; the marker lesion should be > 0.5 cm and 10 g/dL, creatinine 9.0%).
Data sourced from ClinicalTrials.gov (NCT03081858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.