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Clinical Trial VICCURO1382

Title

A Combined Phase 1 and Phase 2 Study of Albumin-bound Rapamycin Nanoparticles (nab-rapamycin, ABI-009) in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer

Principal Investigator(s)

Sam Chang

Details

  • Protocol No. VICCURO1382
  • Open Date: 02/10/2014
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: National
  • Objective: In phase 1, to determine the safety, toxicity, and preliminary efficacy profiles of intravesically administered nab-rapamycin at the maximum deliverable dose (MDD). In phase 2, to evaluate the utility (potential for clinical efficacy) and safety of nabrapamycin in the treatment of BCG refractory or recurrent nonmuscle invasive transitional cell carcinoma (TCC) of the bladder as measured by complete response rate (defined as negative bladder biopsy at 6 weeks post-treatment).
  • Disease Sites: Bladder
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Nab-rapamycin
  • Participating Institutions: Vanderbilt University
  • Secondary Protocol No: Not Specified

Description

None Provided.

Eligibility

Not provided. Please call for more information.