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NCT00722553 · ClinicalTrials.gov registry record · Phase 2
Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder
A Phase 2 study, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00722553: Completed Phase 2 study, sponsored by Acrotech Biopharma.
NCT00722553 is a Phase 2 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00722553, a Phase 2 study, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).
Primary Outcome
The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)
Interventions
- DIETARY_SUPPLEMENT Vitamin B12
- DRUG Pralatrexate Injection
- DIETARY_SUPPLEMENT Folic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
What the finished NCT00722553 record still lists
NCT00722553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Vitamin B12 is the first listed.
NCT00722553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00722553 about?
NCT00722553 is a clinical study titled "Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder". The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additi...
What is the current status of trial NCT00722553?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2008-07. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00722553?
The interventions under investigation include: Vitamin B12 (DIETARY_SUPPLEMENT), Pralatrexate Injection (DRUG), Folic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00722553?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00722553's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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