Safety and Tolerability of TAR-200 mg in Subjects With Non-Muscle-Invasive Bladder Cancer

NCT02720367 | Completed Phase 1

• 2 other identifiers: TAR-200-1022016-000099-66
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if TAR-200, an investigational drug-delivery system is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors (TURBT)

Conditions

Urinary Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Safety as defined by the number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0

  From the point of signing the informed consent form through last study visit, up to 59 days.

Secondary Outcomes (34)

• Number of participants who are tolerant of TAR-200 indwelling (Arm 1)

  From Day 0 up to Day 7

• Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1)

  From Day 0 up to Day 7

• Number of participants who are tolerant of TAR-200 indwelling (Arm 1)

  From Day 21 up to Day 28

• Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1)

  From Day 21 up to Day 28

• Cmax, plasma dFdU (Arm 1)

  From Day 0 up to Day 32

Study Arms (2)

7-Day Regimen

EXPERIMENTAL

TAR-200 is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 7. TAR-200 releases gemcitabine gradually during the 7 day indwelling time. A second TAR-200 is placed in the bladder on Study Day 21 and is removed on Study Day 28, which is the day of the TURBT.

Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200

21-Day Regimen

EXPERIMENTAL

TAR-200 is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 21. TAR-200 releases gemcitabine gradually during the 21 day indwelling time. A second TAR-200 is placed in the bladder on Study Day 21 and is removed on Study Day 42.

Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200

Interventions

Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 DRUG

TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical system whose primary mode of action is the controlled release of gemcitabine into the bladder over an indwelling period.

21-Day Regimen; 7-Day Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A documented history of histologically-confirmed low or intermediate risk urothelial carcinoma of the bladder, excluding carcinoma in situ (pTis), pathologic stage pT1 (invasive into lamina propria) and high-Grade disease, judged not to be muscle infiltrating (pT2 or greater) and accessible for resection.
• Adequate laboratory parameters.
• Screening urinalysis showing no clinically significant abnormalities except those attributable to bladder cancer.
• Not undergoing active treatment in last 3 months for prior or concurrent neoplastic disease and have fully recovered from treatment effects. Patients undergoing concurrent hormonal therapy treatment for prostate cancer will be allowed to enroll.

You may not qualify if:

• Exposure to BCG therapy and/or any other intravesical. chemotherapeutic agent less than 1 year prior to enrollment, except single postoperative instillations.
• Absence of visible tumor at Screening.
• Any previous exposure to intravesical gemcitabine instillations within the past 12 months.
• Presence of any bladder or urethral anatomical feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-200 (i.e. bladder diverticula, complete incontinence).
• Patients with a high-Grade urine cytology at recurrence.
• Currently receiving other systemic or intravesical chemotherapy.
• Pelvic radiotherapy administered within 6 months prior to enrollment. Patients who received radiotherapy ≥ 6 months prior to enrollment must demonstrate no cystoscopic evidence or clinical symptoms of radiation cystitis.
• Bladder Post-Void Residual Volume (PVR) of \> 250-mL.
• History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation.
• Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses ≤5 mg daily.
• Female subject who is pregnant (as verified by urine test at time of screening) or lactating, or of childbearing potential and not using acceptable methods of contraception.
• Unwilling or unable to provide informed consent or comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for scheduled visits and follow-up.
• Other unspecified reasons that, in the opinion of the investigator or TARIS, make the patient unsuitable for enrollment.

Sponsors & Collaborators

• Taris Biomedical LLC: lead

Study Sites (2)

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Johannes Witjes, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 25, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

NL (2)