Clinical trialPhase 2Completed
Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization
Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization for Metastatic Gastrointestinal Neuroendocrine Tumors
- Outcome
- Results posted; single-arm, no comparison
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- November 2006
- Ended
- February 2012
- Enrollment
- 39 participants
- Sites
- 1
- Primary outcomes
- Percentage of Participants With Progression Free Survival (PFS) at 12 Months
- Sponsor type
- Academic / other
- Results posted
- 7 September 2012
- Last update
- 14 September 2012
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Results
- Primary endpoint
- Results posted; single-arm, no comparisonAs posted on ClinicalTrials.gov ↗, registry record of 14 September 2012
- PFS
- Percentage of Participants With Progression Free Survival (PFS) at 12 MonthsSunitinib Malate and Hepatic Artery Embolizations: 66 (51 to 81), n = 39Values: percentage of participants, 95% Confidence IntervalTime frame: 12 monthsNo analysis posted for this outcome (outcome 1)
- Participants
- Sunitinib Malate and Hepatic Artery Embolizations: 39 started, 21 completed
- Serious adverse events
- Sunitinib Malate and Hepatic Artery Embolizations: 3 of 39Participants with at least one serious adverse event, of those at risk, as posted
5 secondary outcomes
- OS · Percentage of Participants With Overall Survival (OS) at One Year
- Sunitinib Malate and Hepatic Artery Emb… 95 (88 to 100), n=39 [percentage of participants, 95% Confidence Interval]
- Number of Participants With Partial Radiographic Response
- Sunitinib Malate and Hepatic Artery Emb… 28, n=39 [participants]
- Number of Participants With Biochemical Response
- Sunitinib Malate and Hepatic Artery Emb… 19, n=39 [participants]
- Number of Participants Requiring Dose Reduction
- Sunitinib Malate and Hepatic Artery Emb… 16, n=39 [participants]
- OS · Percentage of Participants With Overall Survival (OS) at 4 Years
- Sunitinib Malate and Hepatic Artery Emb… 59 (38 to 80), n=39 [percentage of participants, 95% Confidence Interval]
Every value is copied from the trial’s results record at ClinicalTrials.gov. “Statistically significant” describes the posted test only: it does not say which group did better, and nothing here is read from a paper.
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Source text
Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.
Detailed description public domain (ClinicalTrials.gov)
This is a single-center, open-label, non-randomized, prospective phase II trial. Sutent treatment will be continued until disease progression, or excessive toxicity (as determined by treating physician or primary investigator), or until a maximum of eight cycles, whichever duration is shorter.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Percentage of Participants With Progression Free Survival (PFS) at 12 Months [12 months]. Number, percentage of participants (95% Confidence Interval). Sunitinib Malate and Hepatic Artery Embolizations (n=39): 66 (51 to 81).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Participants With Overall Survival (OS) at One Year [12 months]. Number, percentage of participants (95% Confidence Interval). Sunitinib Malate and Hepatic Artery Embolizations (n=39): 95 (88 to 100).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Partial Radiographic Response [12 months]. Number, participants. Sunitinib Malate and Hepatic Artery Embolizations (n=39): 28.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Biochemical Response [12 months]. Number, participants. Sunitinib Malate and Hepatic Artery Embolizations (n=39): 19.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Requiring Dose Reduction [12 months]. Number, participants. Sunitinib Malate and Hepatic Artery Embolizations (n=39): 16.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Percentage of Participants With Overall Survival (OS) at 4 Years [48 months]. Number, percentage of participants (95% Confidence Interval). Sunitinib Malate and Hepatic Artery Embolizations (n=39): 59 (38 to 80).