Study of XL999 in Patients With Acute Myeloid Leukemia (AML) | NCT00322673

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

NCT00322673

Sponsor

Symphony Evolution, Inc.

Status

Terminated

Last Update Posted

Feb 22, 2010Estimated

Enrollment

14Actual

Phase

Phase 2

Conditions

Acute Myeloid Leukemia
AML

Interventions

XL999

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated due to cardiac toxicities

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Nov 2006Actual

Completion Date

May 2007Actual

First Submitted Date

May 4, 2006

First Submission Date that Met QC Criteria

May 4, 2006

First Posted Date

May 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2010

Last Update Posted Date

Feb 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XL999	Drug	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Duration of hematologic response and transfusion independence		Inclusion until disease progression
Progression-free survival		Inclusion until disease progression

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Eddie Hu		Alhambra	California	91801	United States
Ronald Paquette

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms