Status:
TERMINATED
Study of XL999 in Patients With Acute Myeloid Leukemia (AML)
Lead Sponsor:
Symphony Evolution, Inc.
Conditions:
Acute Myeloid Leukemia
AML
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL999 when given weekly to patients with relapsed or newly-diagnosed AML. XL999 is a smal...
Eligibility Criteria
Inclusion
- Diagnosis of acute myeloid leukemia (except AML FAB-M3 or acute promyelocytic leukemia \[APL\]) based on the World Health Organization (WHO) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)
- ECOG performance status of 0 or 1
- Subjects with newly-diagnosed AML or subjects with relapsed AML after at least 2 chemotherapy regimens.
- Adequate liver and renal function
- Signed informed consent
Exclusion
- Anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of XL999 treatment
- Hematopoietic stem cell transplantation within the previous 6 weeks
- Immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (GvHD) within 30 days prior to the start of XL999
- The subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered \> 4 weeks prior to study enrollment
- Uncontrolled and/or concomitant illness
- Pregnant or breastfeeding females
- Known HIV
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00322673
Start Date
May 1 2006
End Date
May 1 2007
Last Update
February 22 2010
Active Locations (7)
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1
Eddie Hu
Alhambra, California, United States, 91801
2
Ronald Paquette
Los Angeles, California, United States, 90095
3
The Thomas and Dorothy Leavey Cancer Center
Northridge, California, United States, 91328
4
David Chan
Redondo Beach, California, United States, 90277