Selumetinib in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00551070
First received: October 22, 2007
Last updated: June 10, 2015
Last verified: July 2014
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Borderline Ovarian Surface Epithelial-stromal Tumor
Ovarian Serous Cystadenocarcinoma
Primary Peritoneal Cavity Cancer
Recurrent Borderline Ovarian Surface Epithelial-stromal Tumor
Interventions: Drug: selumetinib
Other: pharmacological study
Other: laboratory biomarker analysis

  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
The study was activated on 9/22/2008 and closed to accrual on 1/31/2011 (suspended from 1/4/2010 to 8/9/2010).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
AZD6244 AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)

Participant Flow:   Overall Study
    AZD6244  
STARTED     52  
COMPLETED     52  
NOT COMPLETED     0  



  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.
Eligible and treated patients.

Reporting Groups
  Description
AZD6244 AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)

Baseline Measures
    AZD6244  
Number of Participants  
[units: participants]
  52  
Age, Customized  
[units: participants]
 
20-29 years     3  
30-39 years     11  
40-49 years     8  
50-59 years     17  
60-69 years     9  
70-79 years     4  
80-89 years     0  
Gender  
[units: participants]
 
Female     52  
Male     0  



  Outcome Measures
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1.  Primary:   Tumor Response   [ Time Frame: Every other cycle ]

2.  Primary:   Adverse Events (Grade 3 or Higher) During First Cycle of Treatment   [ Time Frame: Cycle 1 ]

3.  Primary:   Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.   [ Time Frame: Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment ]

4.  Primary:   Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.   [ Time Frame: Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment ]

5.  Secondary:   Progression-free Survival   [ Time Frame: Every other cycle ]

6.  Secondary:   Number of Courses Received   [ Time Frame: Every cycle ]

7.  Secondary:   Overall Survival   [ Time Frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years ]


  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
Study began with 100mg BID mix & drink (MD) formulation. AstraZeneca (AZ) switched to hydrogen-sulfate capsule (HC). AZ deemed 100mg BID MD equivalent to 50mg BID HC. As of 12/31/2010, patients got 50mg BID HC; four patients were on treatment then.


  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: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
phone: 716-845-7733
e-mail: kurasa@nrgoncology.org


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00551070     History of Changes
Other Study ID Numbers: NCI-2009-00604, NCI-2009-00604, GOG-0239, CDR0000563965, GOG-0239, GOG-0239, U10CA027469
Study First Received: October 22, 2007
Results First Received: June 10, 2015
Last Updated: June 10, 2015
Health Authority: United States: Food and Drug Administration