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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 is a Phase 2 study that has completed, run by University of Arizona. The registered enrollment target is 10 participants.
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.
Interventions
- DRUG Bendamustine HCL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00867503
The ClinicalTrials.gov registry entry for NCT00867503 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bendamustine HCL is the first listed.
NCT00867503 reports 0 study locations.
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.
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