Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Lipac Oncology, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
RECRUITING · Phase 1
-
KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
RECRUITING · Phase 1
-
A Study of MGC026 in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Sacituzumab Govitecan Plus EV in Metastatic UC
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.