Safety and Tolerability of TAR-200 mg in Subjects With No... | NCT02720367

NCT02720367

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2016-000099-66	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
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.

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Active, uncontrolled urogenital bacterial, viral, or fungal infections, including urinary tract infection. Skin/nail fungal infections are not exclusionary. Subjects with active shingles (varicella zoster infection) will be excluded from the study.
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.

Facility	Status	City	State	ZIP	Country	Contacts
Canisius Wilhelmina Ziekenhuis		Nijmegen			Netherlands
Radboudumc

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms