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

Phase 2
18 Years
Not Enrolling
Acute Myeloid Leukemia, AML

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Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Hematologic and cytogenetic response rate

Outcome Time Frame:

Inclusion until disease progression

Safety Issue:


Principal Investigator

Lynne Bui, MD

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

May 2007

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • acute myeloid leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



American Health Network of Indiana Indianapolis, Indiana  46237
Eddie Hu Alhambra, California  91801
Ronald Paquette Los Angeles, California  90095
The Thomas and Dorothy Leavey Cancer Center Northridge, California  91328
David Chan Redondo Beach, California  90277
Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology Chicago, Illinois  60611
Section of Hematology/Oncology Indiana Cancer Pavilion Indianapolis, Indiana  46202