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Clinical Trial Summary

This research study is studying a targeted therapy known as GO-203-2C as a possible treatment for with acute myeloid leukemia (AML) both alone and in combination with decitabine. GO-203-2c targets cancer cells, while leaving healthy cells unaffected.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.


Clinical Trial Description

- Phase I - The maximum tolerated dose (MTD) will be determined in the phase I section of the trial. - Patients who fulfill eligibility criteria will be entered into the trial to GO-203-2c. - After the screening procedures confirm participation in the research study. The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unmanageable side effects in participants that have acute myeloid leukemia (AML) not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated. - A subsequent dose escalation will evaluate the combination of GO-203-2c and decitabine. - Phase II - The primary goal is to determine if the combination of the two drugs results in clinical response ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02204085
Study type Interventional
Source Beth Israel Deaconess Medical Center
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date September 2014
Completion date December 2024

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