NCT02204085

A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Acute Myeloid Leukemia, in Relapse
• Recurrent Adult Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	GO-203-2c
DRUG	GO-203-2c + Decitabine

Timeline

• Start date: 2014-09-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2014-07-30
• Last updated: 2026-04-03

Locations

2 sites across 1 country: United States