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.
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Full eligibility criteria for NCT01731652
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
If a woman of childbearing potential (WCBP), patient has a negative blood pregnancy test at the Screening visit. For the purposes of this study, WCBP is defined as a post-pubescent female, unless post-menopausal for at least 2 years, surgically sterile, or sexually inactive.
If patient is a WCPB or male patient with a female partner of childbearing potential, must be willing to avoid pregnancy by using an adequate method of contraception from 2 weeks before through 4 weeks after the last study drug treatment. Adequate contraception is defined as follows: 2 barrier methods or 1 barrier method with a spermicide or intrauterine device.
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 has a bleeding disorder, as evidenced by an international normalized ratio
Patient is known to be positive for human immunodeficiency virus (HIV) or has active hepatitis B or C infection.
Patient has a clinically significant active infection at the time of the first study drug treatment.
Patient has any medical or psychiatric condition that, in the Investigator's opinion, might impair the patient's well-being or preclude adherence to the protocol or completing the study as per protocol.
Patient has suspected hypersensitivity to imidazoquinoline compounds, poloxamer 407, hydroxy propyl betacyclodextrin, or lactic acid.
If female, patient is pregnant or breast feeding.
Patient participated in any other protocol involving administration of an investigational agent within 3 months before Day 0.
All locations for NCT01731652
United States (4)
Phoenix, Arizona, United States, 85032
The Urology Center of Colorado
Denver, Colorado, United States, 80211
Urologic Consultants of SE PA
Bala Cynwyd, Pennsylvania, United States, 19004
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
View full eligibility
Tris trial is registered with FDA with number: NCT01731652. The sponsor of the trial is Telormedix SA and it is looking for 12 volunteers for the current phase.
Official trial title: Phase II Pilot Study With TMX 101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer
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