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NCT00436956 · ClinicalTrials.gov registry record · Phase 2
AZD2171 to Treat Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT00436956: Completed Phase 2 study of Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT00436956 is a Phase 2 study of Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 59 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00436956, a Phase 2 study of Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * AZD2171 (Cediranib) is an experimental drug that inhibits formation of new blood vessels. * Tumors need new blood vessels to grow. Preventing the growth of new blood vessels with AZD2171 may inhibit tumor growth. Objectives: -To determine the effectiveness and side effects of AZD2171 in patients with prostate cancer that has metastasized (spread beyond the primary site). Eligibility: * Males 18 years of age and older with androgen-independent prostate cancer that has metastasized. * Patients must have received prior treatment with docetaxel. Design: Patients take one AZD2171 by mouth every day in 28-day treatment cycles and undergo the following procedures: * 1- to 2-day hospitalization at the start of the study for biopsies and blood measurements to determine the level of AZD2171 in the bloodstream. Blood is drawn immediately before the first dose, and 0.25 hr, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, and 48 hours after the dose is taken. * Blood tests before starting treatment and then monthly to determine the level of vascular endothelial growth factor receptor ( VEGFR), a protein involved in blood vessel formation. * Magnetic resonance imaging (MRI) scans once a month to evaluate blood flow. * Tumor biopsies (optional) both before and after the second and sixth treatment cycles. * Clinic visits every 4 weeks, including various routine and research blood tests, urine test and electrocardiogram. * Computed tomography (CT) scan of the chest, abdomen, and pelvis every 8 weeks * Bone scan every 8 weeks Patients record all doses of AZD2171 taken or missed in a pill diary. They record their blood pressure at least once daily in a blood pressure diary. Treatment may continue as long as the patient tolerates the AZD2171 and the cancer does not worsen. ...
Primary Outcome
PFS is the proportion of subjects who progress or die by 6 months after the start of the combined therapy. PFS is determined by prostatic specific antigen (PSA) consensus criteria and the Response Evaluation Criteria in Solid Tumors (RECIST). PSA consensus criteria is defined as PSA decline of \>/= 50% or PSA progression. RECIST is defined as the following: Complete response (CR) is disappearance of all target lesions; partial response (PR) is at least a 30% decline in the sum of the longest dia
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG AZD2171
- PROCEDURE Magnetic Resonance Imaging (DCE-MRI)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2006-10-16 |
| Est. Completion | 2014-02-05 |
| Phase | Phase 2 |
What the finished NCT00436956 record still lists
NCT00436956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Prednisone is the first listed.
NCT00436956 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00436956 about?
NCT00436956 is a clinical study titled "AZD2171 to Treat Prostate Cancer". Background: * AZD2171 (Cediranib) is an experimental drug that inhibits formation of new blood vessels. * Tumors need new blood vessels to grow. Preventing the growth of new blood vessels with AZD2171 may inhibit tumor growth. Objectives: -To determine the effectiveness and side effects of AZD217...
What is the current status of trial NCT00436956?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2006-10-16. Estimated completion is 2014-02-05.
What conditions does trial NCT00436956 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00436956?
The interventions under investigation include: Prednisone (DRUG), AZD2171 (DRUG), Magnetic Resonance Imaging (DCE-MRI) (PROCEDURE).
Who is sponsoring clinical trial NCT00436956?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00436956 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00436956's enrollment target sits among peer trials
59 444th of 735 higher than 290 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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