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A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816)

NCT00536588 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-03-27

No results posted yet for this study

Summary

The purpose of this first-in-human study is to determine the safety and tolerability of SCH 721015 in subjects with transitional cell carcinoma of the bladder.

Conditions

  • Bladder Neoplasms

Interventions

GENETIC

SCH 721015 with SCH 209702

Each subject receives a single intravesical administration of SCH 721015 with SCH 209702 at dose levels of 1 x 10\^9 to 3 x 10\^11 particles/mL (based on assessment of tolerability, intermediate dose levels may be used).

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-08-31
Completion
2009-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536588 on ClinicalTrials.gov