MedTrace Logo

Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

NCT01878188 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-03-11

No results posted yet for this study

Summary

* Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs)
* Recurrence after treatment with BC-819/PEI and BCG
* Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder
* After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly

Conditions

  • Transitional Cell Carcinoma of Bladder

Interventions

DRUG

BC-819/PEI

Intravesical instillation

DRUG

BCG Vaccine

intravesical instillations

Sponsors & Collaborators

  • Anchiano Therapeutics Israel Ltd.

    lead INDUSTRY

Principal Investigators

  • Ami Sidi, MD · Wolfson Medical Center

  • Sarel Halachmi, MD · Bnai-Zion Medical Center, Haifa, Israel

  • Ilan Leibovitch, MD · Meir Medical Center, Kfar-Saba, Israel

  • Ofer Gofrit, MD · Hadassah Ein Karem Medical Center

  • Amnon Zisman, MD · Assaf Harofe Medical Center

  • Abraham Stein, MD · Carmel Hospital,Haifa

  • Haim Matzkin, MD · Tel Aviv Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-10-31
Completion
2017-10-31

Countries

  • Israel

Study Locations

More Related Trials

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 NCT01878188 on ClinicalTrials.gov