Clinical trial NCT00304590: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Symphony Evolution, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Response rate
timeFrame: Inclusion of subject until disease progression
measure: Safety and tolerability
timeFrame: Inclusion until 30 days post last treatment
Secondary outcomes:
measure: Duration of response
timeFrame: Inclusion until disease progression
measure: Progression-free survival
timeFrame: Inclusion until disease progression
measure: Overall survival
timeFrame: Inclusion until 180-day Follow-up or death
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Oncology-Hematology Associates, Ltd.
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
Study officials:
affiliation: Exelixis
name: Lynne Bui, MD
role: STUDY_DIRECTOR
References: