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Safety and Tolerability of TAR-200 in Subjects With Muscle-Invasive Bladder Cancer Who Are Unfit for Radical Cystectomy

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ClinicalTrials.gov Identifier: NCT03404791
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Taris Biomedical LLC

Tracking Information
First Submitted Date  ICMJE December 28, 2017
First Posted Date  ICMJE January 19, 2018
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE January 26, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Number of participants with incidence of treatment emergent adverse events (TEAEs) over 4 consecutive 21-day dosing cycles of TAR-200 as assessed by CTCAE V4.0 [ Time Frame: Study Day 0 to Study Day 84 ]
    Will be assessed through the duration of the study by reported AEs
  • Number of participants that do not require TAR-200 removal prior to the scheduled date of removal due to meeting any of the Subject Stopping Safety Criteria or other drug or device related AE [ Time Frame: Study Day 0 to Study Day 84 ]
    Will be assessed through the duration of the study by reported removals prior to the scheduled date of removal
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03404791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Proportion of subjects with clinical complete response (cCR) [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Will be assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)
  • Proportion of subjects with clinical partial response (cPR) [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Will be assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)
  • Proportion of subjects with stable disease (SD) [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Will be assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)
  • Proportion of subjects with progression [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Will be assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)
  • Symptom control [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Defined as changes in bladder-related symptoms per the protocol-specified bladder symptom and toxicity grading system
  • Time to intervention for symptom control [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Defined as the time from date of the first TAR-200 insertion to the date of intervention for symptom palliation
  • Time to progression [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Defined as the time from the date of the first TAR-200 insertion to the date of first occurrence of progression
  • Proportion of subjects undergoing post-treatment interventions by 3, 6, 9, and 12 months [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Number of subjects undergoing post-treatment interventions compared to all subjects
  • Proportion of subjects surviving at 12 months [ Time Frame: Approximately Study Day 0 to Study Day 360 ]
    Number of subject surviving at 12 months compared to all subjects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of TAR-200 in Subjects With Muscle-Invasive Bladder Cancer Who Are Unfit for Radical Cystectomy
Official Title  ICMJE A Multicenter Study Evaluating Safety and Efficacy of TAR-200 in Subjects With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy
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 muscle-invasive bladder cancer (MIBC) who are unfit for radical cystectomy (RC) during an 84-day induction period comprised of four consecutive 21-day dosing cycles.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer TNM Staging Primary Tumor (T) T2A
  • Bladder Cancer TNM Staging Primary Tumor (T) T2B
  • Bladder Cancer TNM Staging Primary Tumor (T) T3A
  • Bladder Cancer TNM Staging Primary Tumor (T) T3B
Intervention  ICMJE Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per subject.
Study Arms  ICMJE Experimental: Radical Cystectomy Ineligible
TAR-200 is placed into the bladder through an Inserter and gradually releases gemcitabine during the 21-day indwelling period before being removed. Subjects will undergo an 84-day induction period comprised of four consecutive 21-day dosing cycles. Subjects may undergo up to 3 additional dosing cycles as maintenance.
Intervention: Drug: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2018)
15
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder.
  2. Subject must have been as fully resected as possible per the physician's judgment.
  3. Subjects must be deemed unfit for RC due to comorbid conditions with a risk of mortality.
  4. Subjects must refuse or be deemed ineligible for cisplatin-based chemotherapy.
  5. Subject must refuse or not be eligible for radiotherapy.
  6. Life expectancy of at least 4 months.
  7. Adequate bone marrow, liver, and renal function.
  8. Subjects must be willing to undergo a cystoscopy.
  9. Subjects must be willing to undergo a biopsy for assessment of clinical response.
  10. Written informed consent and authorization for release of personal health information obtained according to local laws.
  11. Age ≥18 years at the time of informed consent.
  12. Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation. Subject's partner must also use barrier protection while subject is on study until 4 weeks after treatment discontinuation.
  13. Males must be willing to use an effective method of contraception/method to avoid seminal transfer (barrier method or abstinence) from the time consent is signed until 4 weeks after treatment discontinuation. Subject's partner must also use barrier protection while subject is on study until 4 weeks after treatment discontinuation.
  14. Females of childbearing potential must have a negative pregnancy test within 21 days prior to Study Day 0.

Exclusion Criteria:

  1. Other active malignancies.
  2. 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.
  3. Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed).
  4. Evidence of bladder perforation during diagnostic cystoscopy.
  5. Bladder post-void residual volume (PVR) of >750 mL.
  6. Concurrent clinically significant infections as determined by the treating Investigator.
  7. Known hypersensitivity to gemcitabine (or other drug excipients) or chemically related drugs.
  8. Known hypersensitivity to the device constituent or TARIS Inserter materials.
  9. Use of an investigational product within 30 days or 5 half-lives, whichever is longer, preceding Study Day 0.
  10. Female subject who is lactating/breastfeeding.
  11. Difficulty providing blood samples.
  12. 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.
  13. Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: TARIS Biomedical LLC +1-971-676-7750 clinops@tarisbio.com
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03404791
Other Study ID Numbers  ICMJE TAR-200-103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taris Biomedical LLC
Study Sponsor  ICMJE Taris Biomedical LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kirk A. Keegan, MD, MPH Vanderbilt University Medical Center
PRS Account Taris Biomedical LLC
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP