Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 4, 2006
February 18, 2010
May 2006
November 2006   (final data collection date for primary outcome measure)
  • 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 ]
  • Hematologic and cytogenetic response rate
  • safety and tolerability
Complete list of historical versions of study NCT00322673 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Duration of hematologic response and transfusion independence
  • Progression-free survival
  • Overall survival
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00322673
XL999-207
Yes
Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Symphony Evolution, Inc.
Not Provided
Study Director: Lynne Bui, MD Exelixis, Inc
Symphony Evolution, Inc.
February 2010

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