Spots Global Cancer Trial Database for Guadecitabine in Treating Patients With Higher-Risk Myelodysplastic Syndromes

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Trial Identification

Brief Title: Guadecitabine in Treating Patients With Higher-Risk Myelodysplastic Syndromes

Official Title: Phase 2 Study of SGI-110 in Patients With Higher Risk MDS

Study ID: NCT02131597

Conditions

High Risk Myelodysplastic Syndrome

Interventions

Guadecitabine

Study Description

Brief Summary: This phase II trial studies how well guadecitabine works in treating patients with myelodysplastic syndromes that are at higher risk for becoming acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the complete response (CR) rate with SGI-110 (guadecitabine) in patients with higher risk myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: I. Overall response rate, survival, transformation to acute myeloid leukemia (AML), transfusion independence. II. Safety and toxicity. OUTLINE: Patients receive guadecitabine subcutaneously (SC) on days 1-5. Treatment repeats every 4-8 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 3 courses are taken off therapy after 6 courses. Patients may continue to receive treatment after 24 courses if the investigator determines it is in the patient's best interest. After completion of study treatment, patients are followed up at 30 days, and then every 2 months.