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Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244

This study has been completed.
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
AstraZeneca
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00970359
First received: September 1, 2009
Last updated: March 1, 2017
Last verified: March 2017
Results First Received: October 20, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Thyroid Cancer
Intervention: Biological: AZD6244

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AZD6244

AZD6244: Within 1 week of starting the study: Low iodine diet

The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process.


Participant Flow:   Overall Study
    AZD6244
STARTED   24 
COMPLETED   20 
NOT COMPLETED   4 
Not Treated                4 



  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.
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Reporting Groups
  Description
AZD6244

AZD6244: Within 1 week of starting the study: Low iodine diet

The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process.


Baseline Measures
   AZD6244 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  58.3% 
>=65 years      10  41.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  41.7% 
Male      14  58.3% 
Region of Enrollment 
[Units: Participants]
 
United States   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Whose Tumor(s) Acquire an Increased Propensity for Iodine Uptake as Detected on Iodine-124 Positron Emission Tomography Scan   [ Time Frame: 2 years ]

2.  Primary:   Tumor Response Defined as Either a Complete Response or Partial Response   [ Time Frame: 6 months ]

3.  Secondary:   Change From Baseline in Serum Thyroglobulin Levels After Treatment With 131I   [ Time Frame: At 2 months and 6 months after Radioiodine administration ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alan Ho
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4235
e-mail: hoa@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00970359     History of Changes
Other Study ID Numbers: 09-048
Study First Received: September 1, 2009
Results First Received: October 20, 2015
Last Updated: March 1, 2017