Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00047788
First received: October 18, 2002
Last updated: January 3, 2013
Last verified: January 2013
  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:

Estimated Enrollment: 30
Study Start Date: October 2002
Study Completion Date: May 2004
  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 April 23, 2014