Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer

NCTNCT00427973 (opens ClinicalTrials.gov in a new tab)Other idNCI-2009-00130Other id05-311Other idN02CO12400Other idCDR0000526405

This trial does not test a peptide that PepBank tracks.

  • Names IGF-1 (mecasermin), does not test it. It appears in the description.

Overview

Status
Terminated
Phase
Phase 2
Enrollment
17 participants (actual)
Sponsor
National Cancer Institute (NCI) · Nih
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
May 2009
Primary completion
Apr 2010
Completion
Mar 2012
First posted
29 Jan 2007 (estimated)
Last update posted
31 Oct 2016 (estimated)
Conditions
Adult Primary Hepatocellular Carcinoma · Advanced Adult Primary Liver Cancer · Localized Unresectable Adult Primary Liver Cancer · Recurrent Adult Primary Liver Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. Ph 2

    AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer

    NCT00427973

    May 2009 to Mar 2012

    Terminated

Registry summary

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

Interventions

  • cediranib maleateDrug
  • laboratory biomarker analysisOther
  • computed tomographyProcedure
  • dynamic contrast-enhanced magnetic resonance imagingProcedure
  • pharmacological studyOther

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Progression-free Survival

    Time frame · 3 months

    Registry description

    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%.

Secondary outcomes(2)
  1. Response Rate

    Time frame · Up to 1 year

    Registry description

    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

  2. Overall Survival

    Time frame · The time from study entry until death from any cause, assessed up to 1 year

    Registry description

    Overall survival will be calculated using the Kaplan-Meier method, and confidence limits for survival estimates will be calculated using the Greenwood formula.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 3 months

Progression-free Survival

GroupValue (percentage of participants)
Singe Arm Open Label Study With AZD2171 at 30 mg Daily77
Secondary and other outcome results(3)
Secondary outcomeNumber· Up to 1 year

Response Rate

GroupValue (participants with confirmed response)
Singe Arm Open Label Study With AZD2171 at 30 mg Daily0
Secondary outcomeMedian· The time from study entry until death from any cause, assessed up to 1 year

Overall Survival

GroupValue (months)
Singe Arm Open Label Study With AZD2171 at 30 mg Daily11.7
Post hoc outcomeNumber· May 2009 through January 2010

Discontinued Treatment Due to SAE

GroupValue (Participants)
Singe Arm Open Label Study With AZD2171 at 30 mg Daily0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 1717 / 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

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultZhu AX, Ancukiewicz M, Supko JG, Sahani DV, Blaszkowsky LS, Meyerhardt JA, Abrams TA, McCleary NJ, Bhargava P, Muzikansky A, Sheehan S, Regan E, Vasudev E, Knowles M, Fuchs CS, Ryan DP, Jain RK, Duda DG. Efficacy, safety, pharmacokinetics, and biomarkers of cediranib monotherapy in advanced hepatocellular carcinoma: a phase II study. Clin Cancer Res. 2013 Mar 15;19(6):1557-66. doi: 10.1158/1078-0432.CCR-12-3041. Epub 2013 Jan 29. PMID 23362324

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Histologically or cytologically confirmed hepatocellular carcinoma * Locally advanced unresectable OR metastatic disease * Cancer of the Liver Italian Program (CLIP) score =\< 3 * Symptomatic congestive heart failure * Unstable angina pectoris * Measurable disease, defined as \>= 1 unidimensionally measurable lesion\>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan * Cardiac arrhythmia * Measurable lesion must be outside field of prior chemoembolization * No known brain metastases * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \> 12 weeks * Absolute neutrophil count \>= 1,000/mm\^3 * Platelet count \>= 75,000/mm\^3 * Hemoglobin \>= 8 g/dL * Bilirubin =\< 3.0 mg/dL * AST and ALT =\< 7 times upper limit of normal * Creatinine =\< 2.0 mg/dL * Fertile patients must use effective contraception * CLIP score =\< 3 Exclusion Criteria: * Not pregnant or nursing * Negative pregnancy test * No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD2171 * No chronic diarrhea or any disorder that would limit adequate absorption of AZD2171 * No familial history of long QT syndrome * Proteinuria =\< +1 on two consecutive dipsticks taken no less than 1 week apart * No other uncontrolled illness including, but not limited to, any of the following: * Hypertension * Ongoing or active infection * No psychiatric illness or social situation that would limit study compliance * Recovered from prior therapy * Prior systemic chemotherapy regimens for hepatocellular carcinoma allowed * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * More than 4 weeks since prior radiotherapy, major surgery, or chemoembolization * At least 30 days since prior participation in an investigational trial * No other concurrent investigational agents * No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine) * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer agents or therapies * No mean QTc \> 470 msec (with Bazett's correction) on screening EKG (490 msec for women)

PepBank is a research reference. Talk to a doctor before you use any peptide.