Progression-free Survival
| Group | Value (percentage of participants) |
|---|---|
| Singe Arm Open Label Study With AZD2171 at 30 mg Daily | 77 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: The study was stopped prior to 2nd stage.
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 stopped early · 1 with posted results
AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer
NCT00427973May 2009 to Mar 2012
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase II trial is studying how well AZD2171 works in treating patients with locally advanced unresectable or metastatic liver cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Experimental
AZD2171
Patients will receive AZD2171 (cediranib maleate) 30mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
Outcomes the sponsor listed as primary.
Progression-free Survival
Time frame · 3 months
Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first. This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%.
Response Rate
Time frame · Up to 1 year
Number of patients who achieve either complete or partial response based on RECIST Criteria for target lesions assessed by MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Overall Survival
Time frame · The time from study entry until death from any cause, assessed up to 1 year
Overall survival will be calculated using the Kaplan-Meier method, and confidence limits for survival estimates will be calculated using the Greenwood formula.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Singe Arm Open Label Study With AZD2171 at 30 mg Daily | 77 |
| Group | Value (participants with confirmed response) |
|---|---|
| Singe Arm Open Label Study With AZD2171 at 30 mg Daily | 0 |
| Group | Value (months) |
|---|---|
| Singe Arm Open Label Study With AZD2171 at 30 mg Daily | 11.7 |
| Group | Value (Participants) |
|---|---|
| Singe Arm Open Label Study With AZD2171 at 30 mg Daily | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Singe Arm Open Label Study With AZD2171 at 30 mg DailyPatients will receive AZD2171 (cediranib maleate) at 30 mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed. cediranib maleate: Given orally laboratory biomarker analysis computed tomography dynamic contrast-enhanced magnetic resonance imaging pharmacological study | – | 5 / 17 | 17 / 17 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated