Urinary Bladder CancerPhase 1NCT02722538
Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer
A Phase 1 study testing Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 in people with Urinary Bladder Cancer, run by Taris Biomedical LLC at 6 sites in 2 countries.
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 muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Cancer
- What is being tested?
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 31 May 2016to 2 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III). Subjects with evidence of metastatic nodal disease to the obuturator or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of fixation of the pelvic sidewall are not eligible.
- In Arm 1, subjects must have residual visible tumor following TURBT. In Arm 2, subjects must be fully resected (i.e., no visible tumor or as little tumor as possible) after restaging TURBT 2-6 weeks prior to Study Day 0.
- Adequate bone marrow, liver, and renal function, as assessed by the following requirements conducted within 21 days prior to dosing:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
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- Total bilirubin ≤ 1.5xULN (upper limit of normal)
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5xULN
- Glomerular Filtration Rate (GFR) ≥ 30% (≥ 30 ml/min/1.73 m2)
- Subjects must be willing to undergo a cystoscopy on study for investigational product removal.
- Eligible for and willing to undergo RC per the attending urologist.
- Subjects must be deemed ineligible for cisplatin-based combination chemotherapy by the attending medical oncologist.
- Subjects medically eligible for neoadjuvant cisplatin-based combination chemotherapy who refuse this therapeutic option and understand the risks and benefits of doing so.
- Prior radiation therapy is allowed provided that no radiation therapy was administered to the urinary bladder.
- Written informed consent and Health Insurance Portability and Accountability Act of 1966 (HIPAA) authorization for release of personal health information.
- Age > 18 years at the time of consent.
Who cannot join
- Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other prior systemic chemotherapy for a non-urothelial carcinoma must have been completed > 5 years prior to initiation of study.
- Previous exposure to gemcitabine instillations.
- Currently receiving other intravesical chemotherapy.
- Concurrent clinically significant infections as determined by the treating investigator.
- Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-200.
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- Documented history of vesicoureteral reflux or the presence of an indwelling ureteral stent or nephrostomy tube at the time of screening.
- Pelvic radiotherapy administered within less than 6 months prior to enrollment. Subjects who received radiotherapy ≥ 6 months prior to enrollment must demonstrate no cystoscopic evidence or 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 that in the opinion of the investigator, contraindicates participation. 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.
- History of diagnosis of neurogenic bladder.
- Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses ≤ 5 mg daily.
- Difficulty providing blood samples.
- 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 subject unsuitable for enrollment.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland
University of Chicago Medical Center
Chicago, Illinois
Ohio State University Wexner Medical Center
Columbus, Ohio
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Muscle-Invasive Transitional Cell Carcinoma of the Bladder
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC).
- Conditions
- Urinary Bladder Cancer
- Being tested
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200Drug
TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical drug delivery system, regulated as a drug, whose primary mode of action is the controlled release of gemcitabine into the bladder over a 7-day period.
| Study group | Role | What they receive |
|---|---|---|
| Residual Tumor following TURBT | 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 Radical Cystectomy (RC). Receives: Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 |
| No Residual Tumor Following TURBT | 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 Radical Cystectomy (RC). Receives: Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0
Measured: Maximum 132 days
Secondary outcomes (30)
Number of participants who are tolerant of TAR-200 indwelling
Measured: From Day 0 up to Day 7
Percentage of participants who are tolerant of TAR-200 indwelling
Measured: From Day 0 up to Day 7
Number of participants who are tolerant of TAR-200 indwelling
Measured: From Day 21 up to Day 28
Percentage of participants who are tolerant of TAR-200 indwelling
Measured: From Day 21 up to Day 28
Cmax, plasma dFdU
Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in plasma.
Measured: From Day 0 up to Day 28
Tmax, plasma dFdU
Analysis of Tmax (Day at which maximum concentration was achieved) of diflourodeoxyuridine (dFdU) in plasma.
Measured: From Day 0 up to Day 28
Cavg, plasma dFdU
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
Measured: From Day 0 up to Day 28
Cmax, plasma dFdC
Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma
Measured: From Day 0 up to Day 28
Tmax, plasma dFdC
Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in plasma
Measured: From Day 0 up to Day 28
Cavg, plasma dFdC
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
Measured: From Day 0 up to Day 28
Cmax, urine dFdU (Arm 1 only)
Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in urine
Measured: From Day 0 up to Day 28
Tmax, urine dFdU (Arm 1 only)
Analysis of Cmax (maximum concentration achieved over time) of diflourodeoxyuridine (dFdU) in urine
Measured: From Day 0 up to Day 28
Cavg, urine dFdU (Arm 1 only)
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
Measured: From Day 0 up to Day 28
Cmax, urine dFdC (Arm 1 only)
Analysis of Cmax (maximum concentration achieved over time) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine
Measured: From Day 0 up to Day 28
Tmax, urine dFdC (Arm 1 only)
Analysis of Tmax (Day at which maximum concentration was achieved) of gemcitabine (deoxydifluorocytidine hydrochloride - dFdC) in urine
Measured: From Day 0 up to Day 28
Cavg, urine dFdC (Arm 1 only)
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.
Measured: From Day 0 up to Day 28
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (AKT) (Arm 1)
Measured: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD31) (Arm 1)
Measured: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (Ki67) (Arm 1)
Measured: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (TUNEL) (Arm 1)
Measured: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD4) (Arm 1)
Measured: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD8) (Arm 1)
Measured: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (PD-L1) (Arm 1)
Measured: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (AKT) (Arm 2)
Measured: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD31) (Arm 2)
Measured: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (Ki67) (Arm 2)
Measured: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (TUNEL) (Arm 2)
Measured: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD4) (Arm 2)
Measured: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD8) (Arm 2)
Measured: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (PD-L1) (Arm 2)
Measured: Anti-tumor analysis will occur at study visit Day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start31 May 2016
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taris Biomedical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siamak Daneshmand, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722538
- Sponsor's protocol ID
- TAR-200-101
- Status last verified
- Sep 2023
- First submitted
- 25 Feb 2016
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
Publications
Daneshmand S, Brummelhuis ISG, Pohar KS, Steinberg GD, Aron M, Cutie CJ, Keegan KA, Maffeo JC, Reynolds DL, Raybold B, Chau A, Witjes JA. The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial. Urol Oncol. 2022 Jul;40(7):344.e1-344.e9. doi: 10.1016/j.urolonc.2022.02.009. Epub 2022 Apr 14.
PubMed 35431132
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Muscle-Invasive Transitional Cell Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT02722538
- Acronym / sponsor ID
- TAR-200-101
- Conditions
- Urinary Bladder Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Taris Biomedical LLCIndustry (pharma, biotech, devices)
- Study start
- 31 May 2016 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residual Tumor following TURBT | Experimental | Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200TAR-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 Radical Cystectomy (RC). |
| No Residual Tumor Following TURBT | Experimental | Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200TAR-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 Radical Cystectomy (RC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III). Subjects with evidence of metastatic nodal disease to the obuturator or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of fixation of the pelvic sidewall are not eligible.
- In Arm 1, subjects must have residual visible tumor following TURBT. In Arm 2, subjects must be fully resected (i.e., no visible tumor or as little tumor as possible) after restaging TURBT 2-6 weeks prior to Study Day 0.
- Adequate bone marrow, liver, and renal function, as assessed by the following requirements conducted within 21 days prior to dosing:
- Subjects must be willing to undergo a cystoscopy on study for investigational product removal.
- Eligible for and willing to undergo RC per the attending urologist.
Key exclusion criteria (16 listed)
- Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other prior systemic chemotherapy for a non-urothelial carcinoma must have been completed > 5 years prior to initiation of study.
- Previous exposure to gemcitabine instillations.
- Currently receiving other intravesical chemotherapy.
- Concurrent clinically significant infections as determined by the treating investigator.
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 |
|---|---|---|
| Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical drug delivery system, regulated as a drug, whose primary mode of action is the controlled release of gemcitabine into the bladder over a 7-day period. | Drug | No Residual Tumor Following TURBT, Residual Tumor following TURBT |
Primary outcome
Number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0
Time frame: Maximum 132 days
30 secondary outcomes
Number of participants who are tolerant of TAR-200 indwelling
Time frame: From Day 0 up to Day 7
Percentage of participants who are tolerant of TAR-200 indwelling
Time frame: From Day 0 up to Day 7
Number of participants who are tolerant of TAR-200 indwelling
Time frame: From Day 21 up to Day 28
Percentage of participants who are tolerant of TAR-200 indwelling
Time frame: From Day 21 up to Day 28
Cmax, plasma dFdU
Time frame: From Day 0 up to Day 28
Tmax, plasma dFdU
Time frame: From Day 0 up to Day 28
Cavg, plasma dFdU
Time frame: From Day 0 up to Day 28
Cmax, plasma dFdC
Time frame: From Day 0 up to Day 28
Tmax, plasma dFdC
Time frame: From Day 0 up to Day 28
Cavg, plasma dFdC
Time frame: From Day 0 up to Day 28
Cmax, urine dFdU (Arm 1 only)
Time frame: From Day 0 up to Day 28
Tmax, urine dFdU (Arm 1 only)
Time frame: From Day 0 up to Day 28
Cavg, urine dFdU (Arm 1 only)
Time frame: From Day 0 up to Day 28
Cmax, urine dFdC (Arm 1 only)
Time frame: From Day 0 up to Day 28
Tmax, urine dFdC (Arm 1 only)
Time frame: From Day 0 up to Day 28
Cavg, urine dFdC (Arm 1 only)
Time frame: From Day 0 up to Day 28
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (AKT) (Arm 1)
Time frame: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD31) (Arm 1)
Time frame: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (Ki67) (Arm 1)
Time frame: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (TUNEL) (Arm 1)
Time frame: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD4) (Arm 1)
Time frame: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD8) (Arm 1)
Time frame: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (PD-L1) (Arm 1)
Time frame: Anti-tumor analysis will occur at study visit Day 28.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (AKT) (Arm 2)
Time frame: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD31) (Arm 2)
Time frame: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (Ki67) (Arm 2)
Time frame: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (TUNEL) (Arm 2)
Time frame: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD4) (Arm 2)
Time frame: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (CD8) (Arm 2)
Time frame: Anti-tumor analysis will occur at study visit Day 42.
Preliminary anti-tumor effects assessed in tumor material (post-treatment) for immunohistochemical tissue biomarkers of drug-induced cell death (PD-L1) (Arm 2)
Time frame: Anti-tumor analysis will occur at study visit Day 42.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 35431132Daneshmand S, Brummelhuis ISG, Pohar KS, Steinberg GD, Aron M, Cutie CJ, Keegan KA, Maffeo JC, Reynolds DL, Raybold B, Chau A, Witjes JA. The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial. Urol Oncol. 2022 Jul;40(7):344.e1-344.e9. doi: 10.1016/j.urolonc.2022.02.009. Epub 2022 Apr 14.
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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.
Siamak Daneshmand, MD principal investigator
University of Southern California
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 in people with Urinary Bladder Cancer, run by Taris Biomedical LLC at 6 sites in 2 countries.
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 16 inclusion and 16 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Netherlands. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0 (time frame: Maximum 132 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722538, which also lists 1 linked publication.
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 18 Sep 2023.