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

March 16, 2006
February 18, 2010
February 2006
December 2006   (final data collection date for primary outcome measure)
  • 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 ]
  • Response rate
  • Safety and tolerability
Complete list of historical versions of study NCT00304590 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Duration of response
  • Progression-free survival
  • Overall survival
Not Provided
Not Provided
 
Study of XL999 in Patients With Multiple Myeloma
A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
May 2007
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00304590
XL999-203
Yes
Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Symphony Evolution, Inc.
Not Provided
Study Director: Lynne Bui, MD Exelixis, Inc
Symphony Evolution, Inc.
February 2010

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