NCT00304590

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

10 months

First QC Date

March 16, 2006

Last Update Submit

February 18, 2010

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Inclusion of subject until disease progression

  • Safety and tolerability

    Inclusion until 30 days post last treatment

Secondary Outcomes (3)

  • Duration of response

    Inclusion until disease progression

  • Progression-free survival

    Inclusion until disease progression

  • Overall survival

    Inclusion until 180-day Follow-up or death

Interventions

XL999DRUG

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCLA Oncology-Hematology Associates, Ltd.

Los Angeles, California, 90095, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, 60435, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Lynne Bui, MD

    Exelixis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 20, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2006

Study Completion

May 1, 2007

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

US(3)