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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00322673
• Other study ID #: XL999-207
• Status: Terminated
• Phase: Phase 2
• First received: May 4, 2006
• Last updated: February 18, 2010
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: February 2010
• Source: Symphony Evolution, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• AML
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• XL999
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

Locations

Country	Name	City	State
United States	Eddie Hu	Alhambra	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	Ronald Paquette	Los Angeles	California
United States	The Thomas and Dorothy Leavey Cancer Center	Northridge	California
United States	David Chan	Redondo Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Symphony Evolution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic and cytogenetic response rate		Inclusion until disease progression	No
Primary	Safety and tolerability		Inclusion until 30 dyas post last treatment	Yes
Secondary	Duration of hematologic response and transfusion independence		Inclusion until disease progression	No
Secondary	Progression-free survival		Inclusion until disease progression	No
Secondary	Overall survival		Inclusion until 180-day Follow-up post last treatment or death	No