Trials Sponsors Conditions Drugs Pricing

Conditions

Carcinoma in Situ Non Muscle Invasive Bladder Cancer

Keywords

bladder cancercarcinoma in situnon muscle invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

To assess the activity of TMX-101, as determined by the number of patients who experience complete response (CR).
5 to 7 weeks after the last TMX -101 instillation

Secondary Outcomes (1)

Proportion of patients experiencing adverse events (AEs), including serious adverse events (SAEs) and AEs leading to discontinuation from the study.
Patients will be followed through treatment and follow-up, for an expected total period of up to 13 weeks.

Study Arms (1)

TMX-101

EXPERIMENTAL

TMX-101 0.4% (200 mg in 50 ml) instilled in the bladder once weekly for 6 weeks

Drug: TMX-101

Interventions

TMX-101Drug

Also known as: Imiquimod

TMX-101

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males or female patient is aged ≥18 years.
Pathologically-proven, recurrent, primary, secondary or concomitant carcinoma in situ disease, defined by having either Ta or T1 with CIS, or CIS alone. In cases with T1 tumor lesions, muscularis propria tissue should be in the resected specimen to confirm that it is tumor-free.

Sponsors & Collaborators

Telormedix SA
Industrylead

Study Sites (4)

BCG Oncology

Phoenix, Arizona, 85032, United States

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, 19004, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Related Publications (1)

Donin NM, Chamie K, Lenis AT, Pantuck AJ, Reddy M, Kivlin D, Holldack J, Pozzi R, Hakim G, Karsh LI, Lamm DL, Belkoff LH, Belldegrun AS, Holden S, Shore N. A phase 2 study of TMX-101, intravesical imiquimod, for the treatment of carcinoma in situ bladder cancer. Urol Oncol. 2017 Feb;35(2):39.e1-39.e7. doi: 10.1016/j.urolonc.2016.09.006. Epub 2016 Oct 26.
PMID: 28341495DERIVED

MeSH Terms

Conditions

Carcinoma in SituNon-Muscle Invasive Bladder NeoplasmsUrinary Bladder Neoplasms

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 22, 2012

Study Start

February 2013

Date type not reported

This date has not been verified as actual or estimated.

Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

TMX-101

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

TMX-101

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations