Study of XL999 in Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00304590
• Other study ID #: XL999-203
• Status: Terminated
• Phase: Phase 2
• First received: March 16, 2006
• Last updated: February 18, 2010
• Start date: February 2006
• Est. completion date: May 2007

Study information

• Verified date: February 2010
• Source: Symphony Evolution, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Joliet Oncology-Hematology Associates, Ltd.	Joliet	Illinois
United States	UCLA Oncology-Hematology Associates, Ltd.	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Symphony Evolution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Inclusion of subject until disease progression	No
Primary	Safety and tolerability		Inclusion until 30 days post last treatment	Yes
Secondary	Duration of response		Inclusion until disease progression	No
Secondary	Progression-free survival		Inclusion until disease progression	No
Secondary	Overall survival		Inclusion until 180-day Follow-up or death	No