Status:
TERMINATED
Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Lead Sponsor:
SGX Pharmaceuticals, Inc.
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00129948
Start Date
July 1 2005
End Date
October 1 2007
Last Update
November 3 2006
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Scripps Clinic
La Jolla, California, United States, 92037
2
USC-Norris Neuro-Oncology Program
Los Angeles, California, United States, 90033
3
UCSD Moores Cancer Center
San Diego, California, United States, 92093
4
Univ. of Florida, Baptist Cancer Center
Jacksonville, Florida, United States, 32209