Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SGX Pharmaceuticals, Inc.
• Treatments: Troxacitabine

Criteria

Inclusion Criteria:

• Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting:

refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.

• Patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.

• Patients who are in second relapse, must have had a duration of their second CR or CRp of less than six months.

• Subjects must have adequate organ and immune function as indicated by the following laboratory values:

• Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;

• Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);

• AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).

• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of < 2, and an estimated life expectancy of at least eight weeks.

Exclusion Criteria:

• Clinical evidence of active central nervous system (CNS) leukemic involvement

• Active and uncontrolled infection

• Uncontrolled medical problems unrelated to the malignancy that impair patient ability to give informed consent or unacceptably reduce the safety of the proposed treatment

• Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up

• Known or suspected intolerance or hypersensitivity to Troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients

• A recent history of alcohol or other substance abuse

• Subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment

• Females with a positive pregnancy test at screening

• Subjects who have previously been enrolled into this study and subsequently withdrew