Study of XL999 in Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00304590
Recruitment Status : Terminated (Study was terminated due to cardiac toxicities in the subjects)
First Posted : March 20, 2006
Last Update Posted : February 22, 2010
Information provided by:
Symphony Evolution, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: XL999 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma
Study Start Date : February 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. Response rate [ Time Frame: Inclusion of subject until disease progression ]
  2. Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ]

Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Inclusion until disease progression ]
  2. Progression-free survival [ Time Frame: Inclusion until disease progression ]
  3. Overall survival [ Time Frame: Inclusion until 180-day Follow-up or death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00304590

United States, California
UCLA Oncology-Hematology Associates, Ltd.
Los Angeles, California, United States, 90095
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
Sponsors and Collaborators
Symphony Evolution, Inc.
Study Director: Lynne Bui, MD Exelixis

Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc. Identifier: NCT00304590     History of Changes
Other Study ID Numbers: XL999-203
First Posted: March 20, 2006    Key Record Dates
Last Update Posted: February 22, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases