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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02720367
Other study ID # TAR-200-102
Secondary ID 2016-000099-66
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2016
Est. completion date March 2020

Study information

Verified date March 2020
Source Taris Biomedical LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 2020
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Canisius Wilhelmina Ziekenhuis Nijmegen
Netherlands Radboudumc Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
Taris Biomedical LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of participants who are tolerant of TAR-200 indwelling (Arm 1) From Day 0 up to Day 7
Secondary Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1) From Day 0 up to Day 7
Secondary Number of participants who are tolerant of TAR-200 indwelling (Arm 1) From Day 21 up to Day 28
Secondary Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1) From Day 21 up to Day 28
Secondary Cmax, plasma dFdU (Arm 1) Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in plasma. From Day 0 up to Day 32
Secondary Tmax, plasma dFdU (Arm 1) Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in plasma. From Day 0 up to Day 32
Secondary Cavg, plasma dFdU (Arm 1) Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of diflourodeoxyuridine (dFdU) in plasma. From Day 0 up to Day 32
Secondary Cmax, plasma dFdC (Arm 1) Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma. From Day 0 up to Day 32
Secondary Tmax, plasma dFdC (Arm 1) Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma From Day 0 up to Day 32
Secondary Cavg, plasma dFdC (Arm 1) Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma. From Day 0 up to Day 32
Secondary Cmax, urine dFdU (Arm 1) Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in urine. From Day 0 up to Day 32
Secondary Tmax, urine dFdU (Arm 1) Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in urine From Day 0 up to Day 32
Secondary Cavg, urine dFdU (Arm 1) Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of diflourodeoxyuridine (dFdU) in urine. From Day 0 up to Day 32
Secondary Cmax, urine dFdC (Arm 1) Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine. From Day 0 up to Day 32
Secondary Tmax, urine dFdC (Arm 1) Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine. From Day 0 up to Day 32
Secondary Cavg, urine dFdC (Arm 1) Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine From Day 0 up to Day 32
Secondary Preliminary anti-tumor effects will be assessed in tumor material (post-treatment) for assessment of immunohistochemical tissue biomarkers of drug-induced cell death (AKT, CD31, Ki67, TUNEL). (Arm 1) Anti-tumor analysis will occur at the following study day visit Day 28
Secondary Number of participants who are tolerant of TAR-200 indwelling (Arm 2) From Day 0 up to Day 21
Secondary Percentage of participants who are tolerant of TAR-200 indwelling (Arm 2) From Day 0 up to Day 21
Secondary Number of participants who are tolerant of TAR-200 indwelling (Arm 2) From Day 21 up to Day 42
Secondary Percentage of participants who are tolerant of TAR-200 indwelling (Arm 2) From Day 21 up to Day 42
Secondary Cmax, plasma dFdU (Arm 2) Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in plasma. From Day 0 up to Day 47
Secondary Tmax, plasma dFdU (Arm 2) Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in plasma. From Day 0 up to Day 47
Secondary Cavg, plasma dFdU (Arm 2) Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of diflourodeoxyuridine (dFdU) in plasma. From Day 0 up to Day 47
Secondary Cmax, plasma dFdC (Arm 2) Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma. From Day 0 up to Day 47
Secondary Tmax, plasma dFdC (Arm 2) Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma From Day 0 up to Day 47
Secondary Cavg, plasma dFdC (Arm 2) Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma. From Day 0 up to Day 47
Secondary Cmax, urine dFdU (Arm 2) Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in urine. From Day 0 up to Day 47
Secondary Tmax, urine dFdU (Arm 2) Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in urine From Day 0 up to Day 47
Secondary Cavg, urine dFdU (Arm 2) Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of diflourodeoxyuridine (dFdU) in urine. From Day 0 up to Day 47
Secondary Cmax, urine dFdC (Arm 2) Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine. From Day 0 up to Day 47
Secondary Tmax, urine dFdC (Arm 2) Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine. From Day 0 up to Day 47
Secondary Cavg, urine dFdC (Arm 2) Analysis of Descriptive statistics (e.g. sample size, mean and median, quartiles, minimum and maximum and box plots) of the concentration of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine From Day 0 up to Day 47
Secondary Preliminary anti-tumor effects will be assessed in tumor material (post-treatment) for assessment of immunohistochemical tissue biomarkers of drug-induced cell death (AKT, CD31, Ki67, TUNEL). (Arm 2) Anti-tumor analysis will occur at the following study day visit Day 42
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