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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 4, 2006

Last Updated Date

February 18, 2010

Start Date ^ICMJE

May 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Hematologic and cytogenetic response rate
safety and tolerability

Change History

Complete list of historical versions of study NCT00322673 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Duration of hematologic response and transfusion independence
Progression-free survival
Overall survival

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myeloid Leukemia
AML

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00322673

Other Study ID Numbers ^ICMJE

XL999-207

Has Data Monitoring Committee

Yes

Responsible Party

Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.

Study Sponsor ^ICMJE

Symphony Evolution, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lynne Bui, MD

Exelixis, Inc.

Information Provided By

Symphony Evolution, Inc.

Verification Date

February 2010

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

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