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NCT00867503 · ClinicalTrials.gov registry record · Phase 2
Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer
A Phase 2 study, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00867503: Completed Phase 2 study, sponsored by University of Arizona.
NCT00867503 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00867503, a Phase 2 study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The study design is a non-randomized, open label, single center Phase II trial. Eligible patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary peritoneal serous papillary carcinoma who have relapsed or are refractory to therapy after primary treatment of their disease. Patients will be treated with bendamustine Hydrochloride 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2. 20 patients will be enrolled in the study. OBJECTIVES Hypothesis/Rationale: To determine the efficacy and safety of bendamustine hydrochloride, in women with platinum and taxane refractory ovarian cancer.
Primary Outcome
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria or Cancer Antigen (CA)125 response using the modified Gynecologic Cancer Intergroup(GCIG) criteria
Interventions
- DRUG Bendamustine HCL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT00867503 record still lists
NCT00867503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Bendamustine HCL is the first listed.
NCT00867503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00867503 about?
NCT00867503 is a clinical study titled "Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer". The study design is a non-randomized, open label, single center Phase II trial. Eligible patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary peritoneal serous papillary carcinoma who have relapsed or are refractory to therapy after primary treatment of their ...
What is the current status of trial NCT00867503?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2009-02. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00867503?
The interventions under investigation include: Bendamustine HCL (DRUG).
Who is sponsoring clinical trial NCT00867503?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00867503's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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