Study of XL999 in Patients With Multiple Myeloma

February 18, 2010 updated by: Symphony Evolution, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Oncology-Hematology Associates, Ltd.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: Inclusion until 30 days post last treatment
Inclusion until 30 days post last treatment
Response rate
Time Frame: Inclusion of subject until disease progression
Inclusion of subject until disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Inclusion until disease progression
Inclusion until disease progression
Duration of response
Time Frame: Inclusion until disease progression
Inclusion until disease progression
Overall survival
Time Frame: Inclusion until 180-day Follow-up or death
Inclusion until 180-day Follow-up or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symphony Evolution, Inc.

Investigators

  • Study Director: Lynne Bui, MD, Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (Estimate)

March 20, 2006

Study Record Updates

Last Update Posted (Estimate)

February 22, 2010

Last Update Submitted That Met QC Criteria

February 18, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL999-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on XL999

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe