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
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: XL999
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: February 2006
Study Completion Date: May 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304590

Locations
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.
Investigators
Study Director: Lynne Bui, MD Exelixis, Inc
  More Information

No publications provided

Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
ClinicalTrials.gov Identifier: NCT00304590     History of Changes
Other Study ID Numbers: XL999-203
Study First Received: March 16, 2006
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014