Study of XL999 in Patients With Multiple Myeloma
This study has been terminated.
(Study was terminated due to cardiac toxicities in the subjects)
Sponsor:
Symphony Evolution, Inc.
Information provided by:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00304590
First received: March 16, 2006
Last updated: February 18, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: XL999 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by Symphony Evolution, Inc.:
Primary Outcome Measures:
- Response rate [ Time Frame: Inclusion of subject until disease progression ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Duration of response [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Inclusion until 180-day Follow-up or death ] [ Designated as safety issue: No ]
| Enrollment: | 4 |
| Study Start Date: | February 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304590
Locations
| United States, California | |
| UCLA Oncology-Hematology Associates, Ltd. | |
| Los Angeles, California, United States, 90095 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Joliet Oncology-Hematology Associates, Ltd. | |
| Joliet, Illinois, United States, 60435 | |
Sponsors and Collaborators
Symphony Evolution, Inc.
Investigators
| Study Director: | Lynne Bui, MD | Exelixis, Inc. |
More Information
No publications provided
| Responsible Party: | Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc. |
| ClinicalTrials.gov Identifier: | NCT00304590 History of Changes |
| Other Study ID Numbers: | XL999-203 |
| Study First Received: | March 16, 2006 |
| Last Updated: | February 18, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013