Last updated on June 2018

Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade Stage Ta Non Muscle Invasive Bladder Cancer


Brief description of study

This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder.

Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established).

Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest nontoxic dose (i.e., MTD) established in part 1 of the study.

Clinical Study Identifier: NCT03081858

Contact Investigators or Research Sites near you

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Laurie Nakayama, RN

Trovare Clinical Research
Bakersfield, CA United States
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Recruitment Status: Open


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