Symptoms and General Pathology

All Conditions

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Leukemia, Myeloid

Leukemia, Myeloid, Acute

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Neoplasms by Histologic Type

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Antineoplastic Agents

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Guadecitabine

Azacitidine

Antimetabolites

Enzyme Inhibitors

* SGI-110 daily x5 dosing on a 28-day course
* SGI-110 daily x10 dosing on a 28-day course

* SGI-110 weekly dosing for three weeks on a 28-day course
* SGI-110 twice weekly dosing for three weeks on a 28-day course

* SGI-110 subcutaneous injection administered on Days 1-5
* SGI-110 subcutaneous injection administered on Days 1-5 and 8-12

SGI-110

* SGI-110 administered weekly on Days 1, 8 and 15
* SGI-110 administered weekly on Days 1, 4, 8, 11, 15, and 18

Phase 1-2 dose escalation randomized study in patients with intermediate or high risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML). The Dose Escalation Segment will evaluate the biological activity, preliminary safety and efficacy of SGI-110 with two dosing schedules in MDS and AML patients while the Dose Expansion Segment will further evaluate safety and efficacy at the biological effective dose (BED) or maximum tolerated dose (MTD)as defined in the Dose Escalation Segment.

Once the BED and MTD is determined in the Dose Escalation Segment, the Dose Expansion Segment will randomize patients with MDS, treatment naïve elderly AML, and relapsed/refractory AML patients to receive the BED or MTD dose. Relapsed/refractory AML patients may also receive SGI-110 on a daily x 10 schedule based on the total dose per cycle evaluated in the Dose Escalation Segment using the 5-daily regimen.

SGI-110 in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

A Phase 1-2, Dose Escalation, Multicenter Study of Two Subcutaneous Regimens of SGI-110, a DNA Hypomethylating Agent, in Subjects With Intermediate or High-Risk Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

* Number of patients with adverse events.
* Incidence of dose limiting toxicities.
* Degree of hypomethylation as measured by LINE-1.

Cmax, Cmin, AUC and other secondary PK parameters of SGI-110 and decitabine in patients during Course 1.

Assess remission duration, hematological improvement and transfusion independence rates as measured by weeks.

Spots Global Cancer Trial Database for intermediate 1, intermediate 2, cmml or high risk mds