MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02514824|
Recruitment Status : Active, not recruiting
First Posted : August 4, 2015
Last Update Posted : February 8, 2019
This research study is studying a targeted therapy as a possible treatment for merkel cell carcinoma.
- The name of the study intervention involved in this study is: MLN0128.
|Condition or disease||Intervention/treatment||Phase|
|Merkel Cell Carcinoma||Drug: MLN0128||Phase 1 Phase 2|
This is a phase I/II clinical trial. A phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "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 may prevent tumor cells from dividing and growing by selectively and potently inhibiting a chemical, mTOR kinase, which regulates cell growth and survival.
Patients with merkel cell carcinoma 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 studying the usefulness of MLN0128 in merkel cell carcinoma cases.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma|
|Actual Study Start Date :||September 22, 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
Investigational mTOR kinase inhibitor
Other Name: INK128
- Maximum Tolerated Dose (MTD) [ Time Frame: 56 days ]Based on MTD in phase I, the recommended dose for phase II (RP2D) will be determined
- Overall Response Rate (ORR) [ Time Frame: From registration to up to 2 years ]
- Overall Survival (OS) [ Time Frame: From registration to up to 2 years ]
- Progression-free survival (PFS) [ Time Frame: From registration to up to 2 years ]
- Adverse Events (AEs) [ Time Frame: 30 days before registration to 30 days after the last dose ]
- Response Biomarkers including p4EBP1, PSK6, pCAD and Merkel cell polyomavirus (MCV) Large T antigen (LT) and small T antigen (ST) [ Time Frame: From registration to up to 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): NCT02514824
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Robert Haddad, MD||Dana-Farber Cancer Institute|