A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT02244463|
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : May 27, 2020
This research study is studying a targeted therapy (ML0N128) as a possible treatment for anaplastic thyroid cancer.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a treatment for any disease.
MLN0128 prevents tumor cells from dividing and growing by selectively and potently inhibiting a chemical, mTOR kinase, which regulates cell growth and survival. Patients with anaplastic thyroid cancer have been observed to sometimes carry genetic alterations in their tumor cells which may make the cancer more sensitive to inhibition by MLN0128.
In this research study,the investigators are investigating usefulness of MLN0128 in metastatic anaplastic thyroid cancer cases.
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Thyroid Cancer Thyroid Cancer||Drug: MLN0128||Phase 2|
Patients who fulfill eligibility criteria will be entered into the trial to receive ML0N128. The participant will be given a study drug-dosing diary for each treatment cycle. After the screening procedures confirm participation in the research study.
- MLN0128 - Fixed doses daily per treatment cycle
The treatment cycles will continue until the participants disease gets worse or is taken off treatment for any other reason.Once treatment has been discontinued the investigators will check on the participants health status by phone for the rest of their life.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2022|
Treatment will be administered on an outpatient basis. MLN0128 at fixed dose will be administered orally, daily for treatment cycle. The participant will be requested to maintain a medication diary of medication. The medication diary will be returned to clinic staff at the end of each cycle. Treatment with MLN0128 will continue until progression or withdrawal of consent.
This is a non-randomized phase II study to investigate efficacy of MLN0128 in metastatic anaplastic thyroid cancer cases.
Other Name: INK128
- Progression Free Survival [ Time Frame: baseline, 4 months ]
- Overall All Response Rate [ Time Frame: 2 Years ]
- Overall Survival Rate [ Time Frame: 2 Years ]
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 2 Years ]
- • Identification of biomarkers predictive of response to therapy with MLN0128 [ 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): NCT02244463
|Contact: Jochen Lorch, MD||617) 632-3090||JLORCH@partners.org|
|United States, California|
|Hoag Memorial Hospital Presbyterian||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Michael Demeure, MD 949-791-6767 Michael.Demeure@hoag.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Jochen Lorch, MD 617-632-3090 firstname.lastname@example.org|
|Principal Investigator: Jochen Lorch, MD|
|United States, Michigan|
|University of Michigan Medical School||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Francis Worden, MD 734-647-8902 email@example.com|
|Principal Investigator:||Jochen Lorch, MD. PhD||Dana-Farber Cancer Institute|