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

Symphony Evolution

Status and phase

Terminated

Phase 2

Conditions

AML

Acute Myeloid Leukemia

Treatments

Drug: XL999

Study type

Interventional

Funder types

Industry

Identifiers

NCT00322673

XL999-207

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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