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NCT00318643 · ClinicalTrials.gov registry record · Phase 1

Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer

A Phase 1 study of Bladder Cancer, sponsored by Halozyme Therapeutics.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
5
Study locations

NCT00318643 is a Phase 1 study of Bladder Cancer that has completed, run by Halozyme Therapeutics. The registered enrollment target is 27 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 3 states.

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The verdict

NCT00318643, a Phase 1 study of Bladder Cancer, has completed, sponsored by Halozyme Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target
5
Study locations

Study Summary

The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer. The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20). Chemophase is being specifically developed for use with other anticancer drug to increase the local penetration of the anticancer drug for the treatment of superficial bladder cancer. In this study, Chemophase will be given in combination with mitomycin C directly into the bladder. Mitomycin C is an anti-tumor drug that is commonly used to treat superficial bladder cancer. It is envisioned that Chemophase with mitomycin C may potentially increase the local penetration of mitomycin C into remaining cancer cells following surgery to treat superficial bladder cancer.

Conditions Studied

Interventions

  • DRUG Mitomycin C
  • DRUG Chemophase

Study Locations (5)

Florida

  • Malcolm Randall Veterans Administration Urology Section (112-C) - Gainesville
  • Advanced Research Institute - New Port Richey
  • James A. Haley Veterans Hospital - Tampa

Arizona

  • BCG Oncology - Phoenix

California

  • MedResearch - La Mesa

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2006-03-30
Est. Completion 2009-08-11
Phase Phase 1

Sponsor

Halozyme Therapeutics

31 total trials

What the Registry Record Tells You About NCT00318643

The ClinicalTrials.gov registry entry for NCT00318643 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Mitomycin C is the first listed.

NCT00318643 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Florida, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT00318643 about?

NCT00318643 is a clinical study titled "Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer". The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer. The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20). Chemophase i...

What is the current status of trial NCT00318643?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2006-03-30. Estimated completion is 2009-08-11.

What conditions does trial NCT00318643 study?

This clinical trial studies the following conditions: Bladder Cancer.

What interventions are being tested in trial NCT00318643?

The interventions under investigation include: Mitomycin C (DRUG), Chemophase (DRUG).

Who is sponsoring clinical trial NCT00318643?

This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00318643 being conducted?

This trial has 5 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.