Status: Closed
Activation Date: 2002OCT02
Closing Date: 2004APR08
Phase: II
Description: A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma
Eligibility: Patients with confirmed diagnosis of multiple myeloma with a measurable serum or urine M-component at initial diagnosis. Patients must have relapsed following first or second line oral alkylating therapy or high dose chemotherapy and stem cell transplant. Patients are not eligible if they relapsed during prior treatment, have had > 2 prior chemotherapy regimens or relapsed within 3 months after last treatment.
Objective: To assess the efficacy of ZD6474 when given orally to patients with relapsed previously treated multiple myeloma. To determine the toxic effects, duration of response, time to progression, and pharmacokinetics profile and characteristics, as well as to examine bone marrow samples in patients with multiple myeloma given ZD6474.
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Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
IND | I145 | 18 | 2 | 1 | 3 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
IND | I145 | 18 | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
IND | I145 | 18 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 |