Selumetinib in Treating Patients With Locally Advanced or Metastatic Liver Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00604721
First received: January 17, 2008
Last updated: May 3, 2013
Last verified: May 2013
Results First Received: June 22, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
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.  


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


No publications provided


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, N01CM62208
Study First Received: January 17, 2008
Results First Received: June 22, 2012
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration