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Study of XL999 in Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XL999
Sponsored by
Symphony Evolution, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Oncology-Hematology Associates, Ltd.
  • University of Chicago
  • Joliet Oncology-Hematology Associates, Ltd.

Outcomes

Primary Outcome Measures

Response rate
Safety and tolerability

Secondary Outcome Measures

Duration of response
Progression-free survival
Overall survival

Full Information

First Posted
March 16, 2006
Last Updated
February 18, 2010
Sponsor
Symphony Evolution, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00304590
Brief Title
Study of XL999 in Patients With Multiple Myeloma
Official Title
A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to cardiac toxicities in the subjects
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Symphony Evolution, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
XL999
Intervention Description
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 Measure Information:
Title
Response rate
Time Frame
Inclusion of subject until disease progression
Title
Safety and tolerability
Time Frame
Inclusion until 30 days post last treatment
Secondary Outcome Measure Information:
Title
Duration of response
Time Frame
Inclusion until disease progression
Title
Progression-free survival
Time Frame
Inclusion until disease progression
Title
Overall survival
Time Frame
Inclusion until 180-day Follow-up or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Bui, MD
Organizational Affiliation
Exelixis
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Oncology-Hematology Associates, Ltd.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Ltd.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of XL999 in Patients With Multiple Myeloma

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