Study of XL999 in Patients With Acute Myeloid Leukemia (AML)

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia

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 small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR, c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.

Inclusion Criteria:

• 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 Criteria:

• 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