Study of XL999 in Patients With Multiple Myeloma

This study has been terminated.

(Study was terminated due to cardiac toxicities in the subjects)

Sponsor:

Information provided by:

Symphony Evolution, Inc.

ClinicalTrials.gov Identifier:

NCT00304590

First received: March 16, 2006

Last updated: February 18, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 16, 2006

Last Updated Date

February 18, 2010

Start Date ^ICMJE

February 2006

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Response rate [ Time Frame: Inclusion of subject until disease progression ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Response rate
Safety and tolerability

Change History

Complete list of historical versions of study NCT00304590 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of response [ 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 or death ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Duration of response
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 Multiple Myeloma

Official Title ^ICMJE

A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma

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 refractory multiple myeloma. XL999 is a small molecule inhibitor of cellular factors including VEGFR, PDGFR, and FGFR that may be involved in multiple myeloma.

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

Multiple Myeloma

Intervention ^ICMJE

Drug: XL999

Treatment consisted of 8 weekly infusions of 2.4 mg/kg of XL999 with each infusion given over 4 hours, unless drug-related toxicity required a dosing delay or adjustment. In the absence of progressive disease and unacceptable toxicity, subjects may have received 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

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females with a diagnosis of MM based on bone marrow aspirate and biopsy with ≥10% plasma cells (or biopsy of a tissue with monoclonal plasma cells), M protein level in the serum or urine, and evidence of end organ or tissue impairment (hypercalcemia, renal insufficiency, anemia, or lytic bone lesions), as defined by The International Myeloma Working Group Criteria (2003), at initial diagnosis (before initiation of chemotherapy)
Measurable disease defined as serum and/or urine M component by electrophoresis
Refractory to or relapsed after 2 prior treatment regimens (chemotherapy, biologic or hematopoietic stem cell transplantation)
Concurrent therapy with a bisphosphonate is acceptable
ECOG performance status of 0 or 1
Life expectancy ≥3 months
Adequate liver function
No other malignancies within 5 years
Signed informed consent

Exclusion Criteria:

Nonsecretory myeloma, monoclonal gammopathy of uncertain significance (MGUS), or smoldering myeloma
Anticancer therapy including chemotherapeutic, biologic, or investigational agents, including dexamethasone, within 30 days of XL999 treatment
Hematopoietic stem cell transplantation within the previous 6 weeks
Radiation to ≥33% of bone marrow within 30 days of XL999 treatment
Subject has not recovered to grade ≤1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs that were administered >30 prior to study enrollment
Uncontrolled and/or intercurrent 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

NCT00304590

Other Study ID Numbers ^ICMJE

XL999-203

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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