GO-203-2C for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Led By David Avigan, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new targeted therapy for AML patients. The therapy, GO-203-2C, is being tested both alone and in combination with decitabine. This is a Phase I/II clinical trial, which means they are testing both the safety and effectiveness of the new therapy.

Who is the study for?

This trial is for adults over 18 with Acute Myeloid Leukemia (AML) that's come back or didn't respond to initial treatment. They should be in decent health otherwise, not pregnant, and willing to use birth control. People with severe heart issues, active infections, recent major surgery, or HIV can't join.

What is being tested?

The study tests GO-203-2C alone and combined with Decitabine as treatments for AML. It aims to find the safest dose of GO-203-2C and see how well it works against leukemia cells without harming normal cells.

What are the potential side effects?

Possible side effects include reactions specific to where the drug acts on cancer cells but may also affect normal cell function leading to blood count changes, fatigue, digestive issues or potential liver and kidney-related symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose of GO-203-2c

Maximum Tolerated Dose of GO-203-2c in combination with decitabine

Secondary study objectives

To determine if therapy GO-203-2c in combination with decitabine results in at least 20% of patients achieving a clinical response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: GO-203-2c + DecitabineExperimental Treatment2 Interventions

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.

Group II: GO-203-2cExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GO-203-2c

2011

Completed Phase 1

~30

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