Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00047788
First received: October 18, 2002
Last updated: January 3, 2013
Last verified: January 2013
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Purpose
The primary objective is to assess the efficacy of ZD6474 when given orally to patients with relapsed multiple myeloma. A minimum of 15 and a maximum of 30 evaluable patients will be entered on study
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: ZD6474 Drug: VEGF-receptor tyrosine kinase (KDR) |
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 Two Study of ZD6474 in Patients With Relapsed Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed diagnosis of multiple myeloma.
- Patients must have a minimum serum M-protein level >=10g/L on serum protein electrophoresis or for patients with light chain only disease, a minimum Bence-Jones protein of 1g/24 hr.
- Patients must have received prior treatment for multiple myeloma: patients may have received 1 or 2 prior regimens of oral alkylating based chemotherapy and must have relapsed following treatment (>= 3 months) OR patients may have relapsed following high dose chemotherapy and SCT as first line treatment provided they have not had any other treatment.
- Lab at inclusion of AGC >= 1.0 x10_9/L and platelets >= 50 x10_9/L Bilirubin, AST and/or ALT <= 1.5 x UNL; creatinine < 2 x UNL, Potassium >= 4.0 mmol/L; calcium and magnesium within normal limits·
- Patients may not have had > 2 prior regimens of chemotherapy and/or prior thalidomide treatment.
- Patients may not have had any non-alkylating based chemotherapy.
Exclusion Criteria:
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >= 5 years.
- Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to registration and must be using effective contraception throughout the study.
- Patients who have relapsed during treatment with oral alkylating chemotherapy.
- Patients who have received more than 2 prior regimens of chemotherapy.
- Patients who have received excluded medication or have excluded medical conditions.
- Patients who have received any non-alkylating based chemotherapy regimens as initial therapy, or as therapy for recurrent disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047788
Locations
| United States, New York | |
| Research Site | |
| New York, New York, United States | |
| Canada, Alberta | |
| Research Site | |
| Edmonton, Alberta, Canada | |
| Canada, Nova Scotia | |
| Research Site | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Research Site | |
| Hamilton, Ontario, Canada | |
| Research Site | |
| London, Ontario, Canada | |
| Research Site | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Research Site | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | ZD6474 Medical Science Director, MD | AstraZeneca |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00047788 History of Changes |
| Obsolete Identifiers: | NCT00052741 |
| Other Study ID Numbers: | 6474IL/0004, IND.145(Canada) |
| Study First Received: | October 18, 2002 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Relapsed Multiple Myeloma |
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 23, 2013