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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322673
Recruitment Status : Terminated (Study was terminated due to cardiac toxicities)
First Posted : May 8, 2006
Last Update Posted : February 22, 2010
Information provided by:
Symphony Evolution, Inc.

May 4, 2006
May 8, 2006
February 22, 2010
May 2006
November 2006   (Final data collection date for primary outcome measure)
  • Hematologic and cytogenetic response rate [ Time Frame: Inclusion until disease progression ]
  • Safety and tolerability [ Time Frame: Inclusion until 30 dyas post last treatment ]
  • Hematologic and cytogenetic response rate
  • Safety and tolerability
Complete list of historical versions of study NCT00322673 on Archive Site
  • 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 ]
  • Duration of hematologic response and transfusion independence
  • Progression-free survival
  • Overall survival
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Study of XL999 in Patients With Acute Myeloid Leukemia (AML)
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • AML
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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2007
November 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Not Provided
Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Symphony Evolution, Inc.
Not Provided
Study Director: Lynne Bui, MD Exelixis
Symphony Evolution, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP