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

Sponsor

SGX Pharmaceuticals, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00129948

Collaborator

(none)

211

Enrollment

Locations

Duration (Months)

10.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute	Drug: Troxatyl™ (troxacitabine)	Phase 2

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. The study will primarily assess the complete response (CR) rate of a 5-day continuous infusion of troxacitabine at 12 mg/m2/day given as second salvage therapy in adult patients with AML, with secondary objectives to determine the overall, relapse-free and event-free survival and remission duration; to determine the duration of response; to determine the complete response with incomplete platelet recovery (CRp) rate; to evaluate the tolerability and safety of 5-day continuous intravenous (IV) infusion of troxacitabine; and to determine the relationship between troxacitabine plasma concentrations, anti-leukemic activity and adverse events. Additional cycles of treatment may be given at the investigator's discretion, provided that the subject does not have progressive disease or experience a dose limiting toxicity. Bone marrow transplantation in responding subjects will be allowed.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage

Study Start Date :

Jul 1, 2005

Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

To determine complete response (CR) rate []

Secondary Outcome Measures

To determine the complete response with incomplete platelet recovery (CRp) rate, and recurrent disease (RD) rates []
Efficacy and safety, preliminary evidence of the anti-tumor activity, determination of Troxatyl™ infusion pharmacokinetic parameters []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic	LaJolla	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
5	Winship Cancer Institute, Emory University Hosp.	Atlanta	Georgia	United States	30322
6	University of Chicago	Chicago	Illinois	United States	60637
7	Loyola University Medical Center	Maywood	Illinois	United States	60153
8	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
9	Harper Hospital - Karmanos Cancer Center	Detroit	Michigan	United States	48201
10	Univ. of Minnesota Medical Center	Minneapolis	Minnesota	United States	55455
11	Washington University School of Medicine	St. Louis	Missouri	United States	63110
12	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
13	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
14	New York Presbyterian Hospital-Cornell Campus	New York	New York	United States	10021
15	Wake Forest Univ. School of Medicine	Winston-Salem	North Carolina	United States	27157
16	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
17	Univ. of South Carolina, Hematology/Oncology Division	Charleston	South Carolina	United States	29425
18	Univ. of Texas, MD Anderson Cancer Center	Houston	Texas	United States	77030
19	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
20	Morgantown Internal Medicine Group	Morgantown	West Virginia	United States	26505