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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: Completed Phase 1 study of Bladder Cancer, sponsored by Halozyme Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MTD was defined as the maximum dose level at which no more than two of six participants experienced dose-limiting toxicities (DLT). DLT was defined as any of the following: * Plasma MMC concentration greater than or equal to (\>=) 100 nanograms (ng)/milliliter (mL) * Adverse event (AE) with a Common Toxicity Criteria (CTC) grade greater than or equal to 3 * New, treatment-emergent diagnosis of bladder fibrosis.
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
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-03-30 |
| Est. Completion | 2009-08-11 |
| Phase | Phase 1 |
What the finished NCT00318643 record still lists
NCT00318643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
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 lists 5 locations in 3 states (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.
Learn More About Clinical Trials
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Where NCT00318643's enrollment target sits among peer trials
27 141st of 175 higher than 33 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
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