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

Phase 2TerminatedNCT00322673
Symphony Evolution, Inc.14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

14

Conditions

Acute Myeloid LeukemiaAML

Interventions

XL999DRUG

XL999 was administered at a dose of 2.4 mg/kg given as a 4-hour IV infusion weekly for 4 weeks. In the absence of progressive disease and unacceptable toxicity, subjects were to receive XL999 treatment weekly for up to 1 year on this study

Eligibility

Sex: ALLMin age: 18 Years
Medical Language ↔ Plain English
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

Locations (7)

Eddie Hu

Alhambra, California, United States

Ronald Paquette

Los Angeles, California, United States

The Thomas and Dorothy Leavey Cancer Center

Northridge, California, United States

David Chan

Redondo Beach, 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

Outcomes

Primary Outcomes

Hematologic and cytogenetic response rate

Time frame: Inclusion until disease progression

Safety and tolerability

Time frame: Inclusion until 30 dyas post last treatment

Secondary Outcomes

Duration of hematologic response and transfusion independence

Time frame: Inclusion until disease progression

Progression-free survival

Time frame: Inclusion until disease progression

Overall survival

Time frame: Inclusion until 180-day Follow-up post last treatment or death

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.