CompletedPhase 2

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

United States12 participantsStarted 2013-02

Plain-language summary

This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Patient has undergone mapping of the bladder between Days -28 and -14, with at least one biopsy providing pathological confirmation of CIS of the bladder. Slides must be available for a central pathology review.
✓. Patient has undergone bladder washing for cytology between Days -28 and -1. In patients in whom Ta or T1 lesion(s) were resected, the bladder washing must have occurred after the resection. Slides must be available for a central cytology review.
✓. Patient has an ECOG performance status 0-2.
✓. Patient has adequate bone marrow, hepatic, and renal function within 4 weeks before Day 0.
✓. Patient has read and understood the informed consent form and is willing and able to give informed consent.
✓. Patient fully understands the requirements of the study and is willing to comply with all study visits and assessments.

Exclusion criteria

✕. Patient has evidence of muscle-invasive disease (i.e., T2 or higher)
✕. In the Investigator's opinion, patient is not able to hold instillation for at least 1 hour.
✕. In the Investigator's opinion, patient cannot tolerate intravesical administration or intravesical surgical manipulation.
✕. Patient has received radiation therapy of pelvis within 12 months before the first study drug treatment.
✕. Patient requires perioperative intravesical chemotherapy.
✕. Patient has a history of malignancy of the upper urinary tract.
✕. Patient has bone marrow impairment as evidenced by:
✕. Patient has renal impairment, as evidenced by:

What they're measuring

To assess the activity of TMX-101, as determined by the number of patients who experience complete response (CR).

Timeframe: 5 to 7 weeks after the last TMX -101 instillation

Trial details

NCT IDNCT01731652

SponsorTelormedix SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

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