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

This study has been terminated.
(Study was terminated due to cardiac toxicities)
Sponsor:
Information provided by:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00322673
First received: May 4, 2006
Last updated: February 18, 2010
Last verified: February 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:
  • Hematologic and cytogenetic response rate [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Inclusion until 30 dyas post last treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of hematologic response and transfusion independence [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Inclusion until 180-day Follow-up post last treatment or death ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Eddie Hu
Alhambra, California, United States, 91801
Ronald Paquette
Los Angeles, California, United States, 90095
The Thomas and Dorothy Leavey Cancer Center
Northridge, California, United States, 91328
David Chan
Redondo Beach, California, United States, 90277
United States, Illinois
Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology
Chicago, Illinois, United States, 60611
United States, Indiana
American Health Network of Indiana
Indianapolis, Indiana, United States, 46202
Section of Hematology/Oncology Indiana Cancer Pavilion
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Symphony Evolution, Inc.
Investigators
Study Director: Lynne Bui, MD Exelixis, Inc
  More Information

No publications provided

Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
ClinicalTrials.gov Identifier: NCT00322673     History of Changes
Other Study ID Numbers: XL999-207
Study First Received: May 4, 2006
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Symphony Evolution, Inc.:
acute myeloid leukemia
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 29, 2014