RAD001 for Patients With Radioiodine Refractory Thyroid Cancer
|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.|
|ClinicalTrials.gov Identifier: NCT00936858|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2009
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer||Drug: RAD001||Phase 2|
- RAD001 will be taken once a day in the morning starting on Day 1 and continue until the participant is no longer participating in the study treatment.
- A history and physical exam will be performed the first day of the study and then once a month. Blood tests including coagulation studies, and thyroid studies will be performed monthly. A urine sample will need to be provided on the first day of treatment and then every 2 months. Imaging consisting of a CT or MRI of the neck, chest and abdomen will be done every 8 weeks after starting RAD001.
- Participants will remain on this research study for up to 24 months. However, if the participants doctor feels that they are benefiting from the study drug and they do not have severe side effects, they may be given the option to continue taking RAD001.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Using RAD001 for Patients With Radioiodine Refractory Thyroid Cancer|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
Taken orally once a day in the morning
Other Name: Afinitor (everolimus)
- Progression free survival [ Time Frame: 2 years ]
- Objective response rate (complete and partial responses by modified RECIST criteria) [ Time Frame: 2 years ]
- 1 year survival [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936858
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Mt. Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jochen Lorch, MD||Dana-Farber Cancer Institute|