A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT02204085|
Recruitment Status : Active, not recruiting
First Posted : July 30, 2014
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia, in Relapse Recurrent Adult Acute Myeloid Leukemia||Drug: GO-203-2c Drug: GO-203-2c + Decitabine||Phase 1 Phase 2|
- 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.
- The primary goal is to determine if the combination of the two drugs results in clinical response
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||July 2021|
Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
GO-203-2c given daily on predetermined schedule of a 28-day treatment cycle
Experimental: GO-203-2c + Decitabine
Dose escalation will occur for GO-203-2c using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
GO-203-2c given daily on predetermined schedule of a 28-day treatment cycle. Decitabine will be administered at a dose of 20mg/m2 on days 8-12 of a 28-day treatment cycle.
Drug: GO-203-2c + Decitabine
- Maximum Tolerated Dose of GO-203-2c [ Time Frame: 28 days ]Phase I
- Maximum Tolerated Dose of GO-203-2c in combination with decitabine [ Time Frame: 28 days ]Phase 1
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 years ]
- To investigate whether GO-203-2c alone and in combination with decitabine is effective in targeting MUC1-C overexpressing AML progenitor cells in the lab [ Time Frame: 2 Years ]
- To assess whether in vitro response to GO-203-2c alone and in combination with decitabine is associated with clinical response [ Time Frame: 2 Years ]
- To determine if therapy with GO-203-2c alone and in combination with decitabine results in decreased engraftment potential of AML progenitor cells in an NSG mouse model [ Time Frame: 2 Years ]
- To determine if therapy GO-203-2c in combination with decitabine results in at least 20% of patients achieving a clinical response [ Time Frame: 2 years ]To determine if therapy GO-203-2c in combination with decitabine results in at least 20% of patients achieving a clinical response (blast response, minor response, partial response, or complete response).
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): NCT02204085
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||David Avigan, MD||Beth Israel Deaconess Medical Center|