Study of XL999 in Patients With Acute Myeloid Leukemia (AML) - Full Text View

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00322673

Purpose

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	Intervention	Phase
Acute Myeloid Leukemia AML	Drug: XL999	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia

Further study details as provided by Exelixis:

Primary Outcome Measures:

Hematologic and cytogenetic response rate
safety and tolerability

Secondary Outcome Measures:

Duration of hematologic response and transfusion independence
Progression-free survival
Overall survival

Estimated Enrollment:	80
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322673

Locations

United States, California

Redondo Beach, California, United States

Alhambra, California, United States, 91801

Northridge, California, United States, 91328

Los Angeles, California, United States, 90095
United States, Florida

Jacksonville, Florida, United States, 32207
United States, Illinois

Chicago, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States, 46202
United States, Maryland

Bethesda, Maryland, United States, 20817
United States, New York

Buffalo, New York, United States

New York, New York, United States

Sponsors and Collaborators

Exelixis

More Information

Study ID Numbers:	XL999-207
Study First Received:	May 4, 2006
Last Updated:	June 26, 2007
ClinicalTrials.gov Identifier:	NCT00322673
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

acute myeloid leukemia
AML

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009