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

Phase 2

Terminated

• Conditions: Acute Myeloid Leukemia; AML

• Registration Number: NCT00322673
• Lead Sponsor: Symphony Evolution, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-04
• Study First Submitted QC: 2006-05-04
• Study First Posted: 2006-05-08
• Primary Completion: 2006-11
• Study Completion: 2007-05
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-18
• Last Update Posted: 2010-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hematologic and cytogenetic response rate	Inclusion until disease progression
Safety and tolerability	Inclusion until 30 dyas post last treatment

Secondary Outcome Measures

Name	Time	Method
Duration of hematologic response and transfusion independence	Inclusion until disease progression
Progression-free survival	Inclusion until disease progression
Overall survival	Inclusion until 180-day Follow-up post last treatment or death

Trial Locations

Locations (7)

David Chan; 🇺🇸 Redondo Beach, California, United States

Eddie Hu; 🇺🇸 Alhambra, California, United States

Ronald Paquette; 🇺🇸 Los Angeles, California, United States

The Thomas and Dorothy Leavey Cancer Center; 🇺🇸 Northridge, California, United States

Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology; 🇺🇸 Chicago, Illinois, United States

American Health Network of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Section of Hematology/Oncology Indiana Cancer Pavilion; 🇺🇸 Indianapolis, Indiana, United States