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NCT00421889 · ClinicalTrials.gov registry record · Phase 1
A Study of Belinostat + Carboplatin or Paclitaxel or Both in Patients With Ovarian Cancer in Need of Relapse Treatment
A Phase 1 study, sponsored by Valerio Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT00421889: Completed Phase 1 study, sponsored by Valerio Therapeutics.
NCT00421889 is a Phase 1 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00421889, a Phase 1 study, has completed, sponsored by Valerio Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The study seeks to assess the safety, pharmacodynamics, pharmacokinetics and efficacy of belinostat (PXD101) administered in combination with carboplatin or paclitaxel or both in patients with solid tumours followed by maximum tolerated dose (MTD) expansion (phase II) in ovarian and bladder cancer patients The clinical trial is now in the MTD (phase II) portion of the study enrolling bladder cancer patients. Enrollment of ovarian patients is complete.
Primary Outcome
To determine the maximum tolerated dose of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin (AUC of 5) and paclitaxel (175 mg/m2).
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG belinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2005-08 |
| Est. Completion | 2009-02 |
| Phase | Phase 1 |
What the finished NCT00421889 record still lists
NCT00421889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT00421889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00421889 about?
NCT00421889 is a clinical study titled "A Study of Belinostat + Carboplatin or Paclitaxel or Both in Patients With Ovarian Cancer in Need of Relapse Treatment". The study seeks to assess the safety, pharmacodynamics, pharmacokinetics and efficacy of belinostat (PXD101) administered in combination with carboplatin or paclitaxel or both in patients with solid tumours followed by maximum tolerated dose (MTD) expansion (phase II) in ovarian and bladder cancer p...
What is the current status of trial NCT00421889?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2005-08. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00421889?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), belinostat (DRUG).
Who is sponsoring clinical trial NCT00421889?
This trial is sponsored by Valerio Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00421889's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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