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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00304590 |
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Date of registration:
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16/03/2006 |
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Primary sponsor: |
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Public title:
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Study of XL999 in Patients With Multiple Myeloma
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Scientific title:
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A Phase 2 Study of XL999 in Subjects With Relapsed/Refractory Multiple Myeloma |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00304590 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lynne Bui, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Exelixis, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Intervention(s)
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Drug: XL999
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Primary Outcome(s)
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Response rate
[Time Frame: Inclusion of subject until disease progression]
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Safety and tolerability
[Time Frame: Inclusion until 30 days post last treatment]
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Secondary Outcome(s)
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Duration of response
[Time Frame: Inclusion until disease progression]
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Overall survival
[Time Frame: Inclusion until 180-day Follow-up or death]
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Progression-free survival
[Time Frame: Inclusion until disease progression]
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Secondary ID(s)
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XL999-203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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