Bladder Cancer Cell TransitionalPhase 1/2NCT03081858
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
A Phase 1/2 study testing TSD-001 in people with Bladder Cancer Cell Transitional and Non-Muscle Invasive Bladder Cancer, run by Lipac Oncology LLC at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer, Bladder Cancer
- What is being tested?
- TSD-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 May 2018to 5 Aug 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 < 2.0 cm in diameter.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Peripheral neuropathy grade 1 or less.
- Adequate hematological, hepatic, and renal parameters; i.e., hemoglobin > 10 g/dL, creatinine < 3.5 mg/dL, bilirubin < 1.5 mg/dL , and aspartate aminotransferase, alanine aminotransferase < 50 U/L, and alkaline phosphatase < 130 U/L.
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- All sexually active subjects of reproductive potential are required to use or start using a reliable method of birth control at least 2 weeks prior to study enrollment, throughout the study, and for at least 3 months following completion of study therapy.
- Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
- For male subjects, the digital rectal examination must not be suspicious for carcinoma of the prostate.
- Able to retain bladder instillations for up to 120 minutes (± 15 minutes).
Who cannot join
- Has an active concurrent malignancy/life-threatening disease. If there is a history of prior malignancies/life-threatening diseases, the subject is to be disease free for at least 5 years. Subjects with other prior malignancies less than 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. Subjects will not be excluded for recurrent NMIBC, basal or squamous cell skin cancers, or noninvasive cancer of the cervix.
- Has positive urine cytology for urothelial malignancy at screening.
- Has an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the subject to receive protocol treatment.
- Previous intravesical therapy within 6 months of study entry.
- Prior radiation to the pelvis.
- Participated in a previous clinical trial or used any investigational drugs, biologics, or devices within 90 days prior to study treatment or plans to use any of these during the course of the study.
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- Has had any previous exposure to paclitaxel or docetaxel in the last 5 years.
- Has or has ever had: upper tract TCC; urethral tumor (prostatic urethra included); any invasive bladder tumor known to be other than tumor Ta, low-grade (G1-G2); any evidence of lymph node or distant metastasis; any bladder tumor with histology other than TCC; or carcinoma in situ (CIS).
- Has a tumor in a bladder diverticulum
- Concurrent treatment with any chemotherapeutic agent.
- History of vesicoureteral reflux.
- An indwelling ureteral stent.
- Has received any pelvic radiotherapy (including external beam and/or brachytherapy.)
- Has a bleeding disorder or a screening platelet count < 100×109/L.
- Has an active diagnosis of interstitial cystitis.
- For subjects with recurrent tumor, the subject had at least a 6-month cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
- Presence of poorly controlled diabetes mellitus (glycated hemoglobin [HgbA1c] > 9.0%).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Trovare Clinical Research
Bakersfield, California, 93301
Chesapeake Urology Associates
Hanover, Maryland, 21076
Tower Urology
Los Angeles, California, 90048
Carolina Urologic Research Clinic
Myrtle Beach, South Carolina, 29572
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741
About this study
Official title: A Phase 1/2a Pilot Study of Intravesical TSD-001 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 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).
Read more
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
- Being tested
- TSD-001
- Keywords
- NMIBC, Paclitaxel, Antineoplastic Agents, Bladder Cancer
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Urinary Bladder Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSD-001Drug
Also called Proliposomal Intravesical Paclitaxel
Administered via intravesical instillation.
| Study group | Role | What they receive |
|---|---|---|
| TSD-001 Administration Part 1, Cohort 1 | Experimental | Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose will be 10 mg in Sterile Water for Injection (SWFI). TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). If Dose Limiting Toxicity(DLT) does not develop, intravesical instillation 14 days later will be titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI) until DLT (defined as any grade 3 or 4 toxicity or prolonged [greater than 14 days] grade 2 toxicity) is observed. Receives: Drug: TSD-001 |
| TSD-001 Administration Part 1, Cohort 2 | Experimental | Part 1, Cohort 1: For the next 3 subjects enrolled, the initial dose will be 90 mg in SWFI. TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). If DLT does not develop, intravesical instillation 14 days later will be titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI) until DLT (defined as any grade 3 or 4 toxicity or prolonged [greater than 14 days] grade 2 toxicity) is observed.
If no DLT is observed in the first 6 subjects (cohorts 1 and 2) after titration up to 540 mg, then the maximum deliverable dose (MDD) will be defined and dose recommended for part 2 of the study. Receives: Drug: TSD-001 |
| TSD-001 Administration Part 2 | Experimental | In part 2, the dose will be selected as the MTD/MDD, established in part 1 and provided weekly via the intravesical route.
During part 2, up to 10 additional subjects will receive intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MTD/MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). Receives: Drug: TSD-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD)
Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.
Measured: 12 weeks
Part 2: Marker Lesion Response Rate
Determine the marker lesion response rate at final assessment visit for subjects that received the MDD established in part 1.
Measured: 12 weeks (Cohort 1) or 15 weeks (Cohort 2)
Secondary outcomes (2)
Part 1: Determine Paclitaxel Concentrations
Determine the local (bladder urine) and systemic (peripheral blood) paclitaxel concentrations before and after intravesical exposure to TSD-001 at all doses. Blood and urine samples were collected 15 (± 15) minutes before and 2 hours (± 10 minutes) after each instillation. Results are presented for different dose levels administered during dose escalation. The remaining results are grouped by cohort.
Measured: 10 weeks
Part 2: Determine Paclitaxel Concentrations
Determine the systemic (peripheral blood) paclitaxel concentrations 15 (± 15) minutes before, and 2 hours (± 10 minutes) after the third intravesical instillation (Week 2) of TSD-001.
Measured: Week 2 (pre and post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start17 May 2018
- Primary completion27 Aug 2020
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder Cancer Cell TransitionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipac Oncology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TesoRx Pharma, LLC
- Responsible party
- Sponsor
- Investigators
- Michael Oefelein, MD, Study director, Lipac Oncology LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081858
- Sponsor's protocol ID
- TD-001
- Status last verified
- Jun 2025
- First submitted
- 10 Mar 2017
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Pilot Study of Intravesical TSD-001 for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT03081858
- Acronym / sponsor ID
- TD-001
- Conditions
- Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer, Bladder Cancer, Urinary Bladder, Transitional Cell Carcinoma of the Bladder, Urinary Bladder Neoplasms
- Keywords
- NMIBC, Paclitaxel, Antineoplastic Agents, Bladder Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lipac Oncology LLCIndustry (pharma, biotech, devices)
- Collaborators
- TesoRx Pharma, LLC
- Study start
- 17 May 2018 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TSD-001 Administration Part 1, Cohort 1 | Experimental | Drug: TSD-001Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose will be 10 mg in Sterile Water for Injection (SWFI). TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). If Dose Limiting Toxicity(DLT) does not develop, intravesical instillation 14 days later will be titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI) until DLT (defined as any grade 3 or 4 toxicity or prolonged [greater than 14 days] grade 2 toxicity) is observed. |
| TSD-001 Administration Part 1, Cohort 2 | Experimental | Drug: TSD-001Part 1, Cohort 1: For the next 3 subjects enrolled, the initial dose will be 90 mg in SWFI. TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). If DLT does not develop, intravesical instillation 14 days later will be titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI) until DLT (defined as any grade 3 or 4 toxicity or prolonged [greater than 14 days] grade 2 toxicity) is observed. If no DLT is observed in the first 6 subjects (cohorts 1 and 2) after titration up to 540 mg, then the maximum deliverable dose (MDD) will be defined and dose recommended for part 2 of the study. |
| TSD-001 Administration Part 2 | Experimental | Drug: TSD-001In part 2, the dose will be selected as the MTD/MDD, established in part 1 and provided weekly via the intravesical route. During part 2, up to 10 additional subjects will receive intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MTD/MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 will be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on subject's tolerability of the procedure). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 < 2.0 cm in diameter.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Peripheral neuropathy grade 1 or less.
Key exclusion criteria (17 listed)
- Has an active concurrent malignancy/life-threatening disease. If there is a history of prior malignancies/life-threatening diseases, the subject is to be disease free for at least 5 years. Subjects with other prior malignancies less than 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. Subjects will not be excluded for recurrent NMIBC, basal or squamous cell skin cancers, or noninvasive cancer of the cervix.
- Has positive urine cytology for urothelial malignancy at screening.
- Has an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the subject to receive protocol treatment.
- Previous intravesical therapy within 6 months of study entry.
- Prior radiation to the pelvis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSD-001Also: Proliposomal Intravesical PaclitaxelAdministered via intravesical instillation. | Drug | TSD-001 Administration Part 1, Cohort 1, TSD-001 Administration Part 1, Cohort 2, TSD-001 Administration Part 2 |
Primary outcome
Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD)
Time frame: 12 weeks
Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.
Part 2: Marker Lesion Response Rate
Time frame: 12 weeks (Cohort 1) or 15 weeks (Cohort 2)
Determine the marker lesion response rate at final assessment visit for subjects that received the MDD established in part 1.
2 secondary outcomes
Part 1: Determine Paclitaxel Concentrations
Time frame: 10 weeks
Part 2: Determine Paclitaxel Concentrations
Time frame: Week 2 (pre and post dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Oefelein, MD study director
Lipac Oncology LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TSD-001 in people with Bladder Cancer Cell Transitional and Non-Muscle Invasive Bladder Cancer, run by Lipac Oncology LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.