Back to resultsStudy of XL999 in Patients With Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia, AML
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XL999
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia, AML
Eligibility 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
Sites / Locations
- Eddie Hu
- Ronald Paquette
- The Thomas and Dorothy Leavey Cancer Center
- David Chan
- Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology
- American Health Network of Indiana
- Section of Hematology/Oncology Indiana Cancer Pavilion
Outcomes
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
Full Information
NCT ID
NCT00322673
First Posted
May 4, 2006
Last Updated
February 18, 2010
Sponsor
Symphony Evolution, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00322673
Brief Title
Study of XL999 in Patients With Acute Myeloid Leukemia (AML)
Official Title
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to cardiac toxicities
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Symphony Evolution, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, AML
Keywords
acute myeloid leukemia, AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
XL999
Intervention Description
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
Primary Outcome Measure Information:
Title
Hematologic and cytogenetic response rate
Time Frame
Inclusion until disease progression
Title
Safety and tolerability
Time Frame
Inclusion until 30 dyas post last treatment
Secondary Outcome Measure Information:
Title
Duration of hematologic response and transfusion independence
Time Frame
Inclusion until disease progression
Title
Progression-free survival
Time Frame
Inclusion until disease progression
Title
Overall survival
Time Frame
Inclusion until 180-day Follow-up post last treatment or death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Bui, MD
Organizational Affiliation
Exelixis
Official's Role
Study Director
Facility Information:
Facility Name
Eddie Hu
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
Ronald Paquette
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
The Thomas and Dorothy Leavey Cancer Center
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
David Chan
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
American Health Network of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Section of Hematology/Oncology Indiana Cancer Pavilion
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of XL999 in Patients With Acute Myeloid Leukemia (AML)
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