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BRIEF TITLE: A Phase 1/2a Pilot Study of Intravesical TSD-001 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


  • Org Study ID: TD-001
  • Secondary ID:
  • NCT ID: NCT03081858
  • NCT Alias:
  • Sponsor: TesoRx Pharma, LLC - Industry
  • Source: TesoRx Pharma, LLC

Brief 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.

Overal Status Start Date Phase Study Type
Recruiting May 17, 2018 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Part 1: Maximum Tolerated Dose

Primary Outcome 1 - Time Frame: 12 weeks

Primary Outcome 2 - Measure: Part 2: Marker Lesion Response Rate

Primary Outcome 2 - Time Frame: 12 weeks

Condition:

  • 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

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 < 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.

- 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).

Exclusion Criteria:

- 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.

- 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%).
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Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Official Information

Name: Michael Oefelein, MD

Role: Study Director

Affiliation: Lipac Oncology LLC

Overall Contact

Name: Michael Oefelein, MD

Phone: 909-595-0500

Email: info@tesorx.com

Locations

Facility Status Contact
Urological Associates of Southern Arizona, PC
Tucson, Arizona 85741
United States
Recruiting Suzan Swanson
520-351-5573
suzans@uasapc.com
Trovare Clinical Research
Bakersfield, California 93301
United States
Recruiting Laurie Nakayama, RN
661-663-3096
lnakayama@trovarecr.com
Tower Urology
Los Angeles, California 90048
United States
Recruiting Shiblee Nomanee
310-854-9898
nomanees@towerurology.com
Chesapeake Urology Associates
Hanover, Maryland 21076
United States
Recruiting Wendy Paxton
443-471-5763
wpaxton@chesuro.com
Carolina Urologic Research Clinic
Myrtle Beach, South Carolina 29572
United States
Recruiting Stacy Rust
843-449-1010
srust@curcmb.com