NCT02891460

Brief Summary

The purpose of this study is to evaluate the clinical response of the tumors within the bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharma's (known at that time as TheraCoat Ltd.) TC-3 Sterile Hydrogel (TC-3) and to evaluate the patency of ureters 6 hr post instillation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

August 31, 2016

Last Update Submit

September 7, 2016

Conditions

Urinary Bladder NeoplasmsUrologic NeoplasmsNeoplasmsUrinary Bladder DiseasesUrologic Diseases

Keywords

Mitomycin CMMCNMIBCNon Muscle Invasive Bladder CancerHydrogel Reverse thermal gelationDrug retentionUrinary Bladder NeoplasmsUrologic NeoplasmsUrinary Bladder DiseasesUrologic Diseases

Outcome Measures

Primary Outcomes (6)

  • Subject's degree of response at 2-4 weeks post-treatment

    Cystoscopic and pathological effect of pre-TURBT intravesical instillations with 40 or 80 mg of MMC mixed with 40cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients

    9-11 weeks

  • Adverse events (AE) including serious adverse events (SAE)

    1.2 years

  • Anesthesia information

    Information of whether anesthesia was used during the treatment will be collected

    7 weeks

  • Blood and urine tests

    Blood and urine tests (including urine culture test) be be collected

    9-11 weeks

  • The degree of pain during treatment

    The degree of pain subject felt at the time the drug will be injected to the bladder will be collected (VAS)

    7 weeks

  • Gel clearance and urinary patency

    Data regarding gel clearance and adverse urinary patency post instillation will be obtained based on the "post instillation telephone follow-up" set of questions.

    7 weeks

Secondary Outcomes (2)

  • Tumor recurrence rate during 12 months post- 2-4 week follow-up visit in complete response (CR) subjects.

    1.2 years

  • Lesion Mass by time point (Screening and 2-4 weeks post-treatment)

    9-11 weeks

Other Outcomes (1)

  • Subjects' satisfaction with the treatment

    9-11 weeks

Study Arms (2)

40 mg MMC in 40 mL TC-3.

EXPERIMENTAL

TC-3 gel mixed with Mitomycin C (MMC) Six weekly intravesical instillations of 40 ml of TC-3 gel mixed with 40 mg MMC will be instilled using catheter.

Device: 40 mg MMC in 40 mL TC-3.

80 mg MMC in 40 mL TC-3.

EXPERIMENTAL

TC-3 gel mixed with Mitomycin C (MMC) Six weekly intravesical instillations of 40 ml of TC-3 gel mixed with 80 mg MMC will be instilled using catheter.

Device: 80 mg MMC in 40 mL TC-3.

Interventions

40 mg MMC in 40 mL TC-3.DEVICE

A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature) for drug retention in the urinary bladder.

Also known as: MMC-Gel
40 mg MMC in 40 mL TC-3.
80 mg MMC in 40 mL TC-3.DEVICE

A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature) for drug retention in the urinary bladder.

Also known as: MMC-Gel
80 mg MMC in 40 mL TC-3.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single or multiple tumors (n≤7)
  • Recurrent or Naive tumor.
  • No prior history of T1 and/or Tis
  • At least one tumor \>1mm.
  • Largest tumor diameter ≤ 30mm
  • Cystoscopic appearance of papillary Low or high grade tumor

You may not qualify if:

  • Carcinoma In Situ (CIS)
  • Over 7 lesions
  • Lesion is larger than 30mm in diameter
  • Cystoscopic appearance suspicious for Tis
  • Tumor located in prostatic urethra
  • Previous systemic chemotherapy or pelvic radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajiv Gandhi Cancer Institute & Research Center

Delhi, New Delhi, 110085, India

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrologic NeoplasmsNeoplasmsUrinary Bladder DiseasesUrologic DiseasesNon-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Sudhir Rawal, MD

    Rajiv Gandhi Cancer Institute & Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 7, 2016

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2015

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

IN(1)