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

February 18, 2010 updated by: Symphony Evolution, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: Inclusion until 30 dyas post last treatment
Inclusion until 30 dyas post last treatment
Hematologic and cytogenetic response rate
Time Frame: Inclusion until disease progression
Inclusion until disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Inclusion until disease progression
Inclusion until disease progression
Overall survival
Time Frame: Inclusion until 180-day Follow-up post last treatment or death
Inclusion until 180-day Follow-up post last treatment or death
Duration of hematologic response and transfusion independence
Time Frame: Inclusion until disease progression
Inclusion until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symphony Evolution, Inc.

Investigators

  • Study Director: Lynne Bui, MD, Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

February 22, 2010

Last Update Submitted That Met QC Criteria

February 18, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL999-207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia

Clinical Trials on XL999

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe