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

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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 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.

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

Details

• Lead Sponsor: Symphony Evolution, Inc.

Criteria

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