Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 2002

Last Updated Date

April 3, 2009

Start Date ^ICMJE

October 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00047788 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer

Official Title ^ICMJE

A Phase Two Study of ZD6474 in Patients With Relapsed Multiple Myeloma

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Drug: ZD6474
Drug: VEGF-receptor tyrosine kinase (KDR)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00047788

Responsible Party

Study ID Numbers ^ICMJE

6474IL/0004, IND.145(Canada)

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ZD6474 Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP