NCT00322673

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

6 months

First QC Date

May 4, 2006

Last Update Submit

February 18, 2010

Conditions

Acute Myeloid LeukemiaAML

Keywords

acute myeloid leukemiaAML

Outcome Measures

Primary Outcomes (2)

  • Hematologic and cytogenetic response rate

    Inclusion until disease progression

  • Safety and tolerability

    Inclusion until 30 dyas post last treatment

Secondary Outcomes (3)

  • Duration of hematologic response and transfusion independence

    Inclusion until disease progression

  • Progression-free survival

    Inclusion until disease progression

  • Overall survival

    Inclusion until 180-day Follow-up post last treatment or death

Interventions

XL999DRUG

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Eddie Hu

Alhambra, California, 91801, United States

Location

Ronald Paquette

Los Angeles, California, 90095, United States

Location

The Thomas and Dorothy Leavey Cancer Center

Northridge, California, 91328, United States

Location

David Chan

Redondo Beach, California, 90277, United States

Location

Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology

Chicago, Illinois, 60611, United States

Location

American Health Network of Indiana

Indianapolis, Indiana, 46202, United States

Location

Section of Hematology/Oncology Indiana Cancer Pavilion

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Lynne Bui, MD

    Exelixis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 4, 2006

First Posted

May 8, 2006

Study Start

May 1, 2006

Primary Completion

November 1, 2006

Study Completion

May 1, 2007

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

US(7)