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Selumetinib in Treating Patients With Locally Advanced or Metastatic Liver Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604721
First Posted: January 30, 2008
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: June 22, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Interventions: Drug: selumetinib
Other: pharmacological study

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZD6244 Treatment The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a "moderate liver dysfunction" safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort.

Participant Flow:   Overall Study
    AZD6244 Treatment
STARTED   19 
COMPLETED   17 [1] 
NOT COMPLETED   2 
Physician Decision                1 
Withdrawal by Subject                1 
[1] 2 patients failed to complete a full cycle of therapy.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD6244 Treatment The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a "moderate liver dysfunction" safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort.

Baseline Measures
   AZD6244 Treatment 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   4 
Age, Customized 
[Units: Years]
Mean (Full Range)
 57 
 (48 to 77) 
Gender 
[Units: Participants]
 
Female   6 
Male   13 
Region of Enrollment 
[Units: Participants]
 
United States   19 


  Outcome Measures
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1.  Primary:   Number of Participants With Radiographic Objective Response (OR)   [ Time Frame: 33 weeks ]

2.  Secondary:   Median Progression Free Survival (PFS)   [ Time Frame: 33 weeks ]

3.  Secondary:   Median Overall Survival (OS)   [ Time Frame: 33 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was stopped at the interim analysis due to lack of radiographic response.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bert. H. O'Neil, Associate Professor, Clinical Research
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-4431
e-mail: bert_oneil@med.unc.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00604721     History of Changes
Obsolete Identifiers: NCT00550719, NCT01656291
Other Study ID Numbers: NCI-2009-00247
07-0973
77782
MCC-07-0973
VU-VICC-GI-0726
GCRC-2625-ORC
MCC-15260
CDR0000571751
N01CM62207 ( U.S. NIH Grant/Contract )
N01CM62208 ( U.S. NIH Grant/Contract )
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: June 22, 2012
Results First Posted: September 6, 2012
Last Update Posted: May 28, 2014