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Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer

NCT02007005 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2015-05-06

No results posted yet for this study

Summary

The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer. Secondary objectives are the local and systemic tolerability, the influence on tumor remission and the influence on the one-year recurrence rate.

Conditions

  • Superficial Bladder Cancer

Interventions

DRUG

abnobaVISCUM Fraxini

intravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs

Sponsors & Collaborators

  • Abnoba Gmbh

    lead INDUSTRY

Principal Investigators

  • Herbert Ruebben, Prof.Dr.Dr. · Director of the Urological Clinic of the University Hospital Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2012-02-29
Completion
2013-09-30

Countries

  • Egypt
  • Germany

Study Locations

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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 NCT02007005 on ClinicalTrials.gov