Efficacy Study of ZD6474 to Treat Multiple Myeloma Cancer

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00047788

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: ZD6474 Drug: VEGF-receptor tyrosine kinase (KDR)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2002

Actual Study Completion Date :

May 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research Site	New York	New York	United States
2	Research Site	Edmonton	Alberta	Canada
3	Research Site	Halifax	Nova Scotia	Canada
4	Research Site	Hamilton	Ontario	Canada
5	Research Site	London	Ontario	Canada
6	Research Site	Toronto	Ontario	Canada
7	Research Site	Montreal	Quebec	Canada

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genzyme, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT00047788

Other Study ID Numbers:

6474IL/0004
IND.145(Canada)
NCT00052741

First Posted:

Oct 21, 2002

Last Update Posted:

Aug 24, 2016

Last Verified:

Aug 1, 2016

Keywords provided by Genzyme, a Sanofi Company

Relapsed Multiple Myeloma

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 24, 2016