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

NCT03081858 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-06-27

Study results available
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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

  • Bladder Cancer Cell Transitional
  • Non-Muscle Invasive Bladder Cancer
  • Bladder Cancer
  • Urinary Bladder
  • Transitional Cell Carcinoma of the Bladder
  • Urinary Bladder Neoplasms
  • Urologic Neoplasms
  • Urogenital Neoplasms
  • Urinary Bladder Diseases
  • Urologic Diseases

Interventions

DRUG

TSD-001

Administered via intravesical instillation.

Sponsors & Collaborators

  • TesoRx Pharma, LLC

    collaborator INDUSTRY

  • Lipac Oncology LLC

    lead INDUSTRY

Principal Investigators

  • Michael Oefelein, MD · Lipac Oncology LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2020-08-27
Completion
2021-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081858 on ClinicalTrials.gov