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

Sponsor

Symphony Evolution, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00322673

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia AML	Drug: XL999	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Hematologic and cytogenetic response rate [Inclusion until disease progression]
Safety and tolerability [Inclusion until 30 dyas post last treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eddie Hu	Alhambra	California	United States	91801
2	Ronald Paquette	Los Angeles	California	United States	90095
3	The Thomas and Dorothy Leavey Cancer Center	Northridge	California	United States	91328
4	David Chan	Redondo Beach	California	United States	90277
5	Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology	Chicago	Illinois	United States	60611
6	American Health Network of Indiana	Indianapolis	Indiana	United States	46202
7	Section of Hematology/Oncology Indiana Cancer Pavilion	Indianapolis	Indiana	United States	46202