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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00256880




Registration number
NCT00256880
Ethics application status
Date submitted
21/11/2005
Date registered
22/11/2005
Date last updated
18/01/2017

Titles & IDs
Public title
Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma
Scientific title
A Phase II, Open-Label Study of Pazopanib (GW786034) in Patients With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
VEG20006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GW786034

Treatment: Drugs: GW786034
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory multiple myeloma (MM).
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with MM.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria:

- Must have diagnosis of relapsed or refractory multiple.

- bone marrow function [ANC (absolute neutrophil count) greater than 1000/mm3]; platelet
count greater than or equal to 75,000/mm3.

- renal function (calculated creatinine clearance >50 mL.min, albumin less than or equal
to 500 mg).
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Failed more than 3 prior lines of therapy including stem cell transplant.

- Females who are pregnant or nursing.

- Unstable blood pressure.

- Significant heart conditions or history of thrombosis.

- Any unstable, pre-existing major medical condition or history of other cancers.

- Have received an investigational drug, chemotherapy, radiation treatment or surgery
within 28 days prior to entering the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine how effective and safe a new investigational drug
is in treating patients with relapsed or refractory multiple myeloma. The treatment involves
daily dosing. A patient may continue to receive the treatment as long as they are benefiting
from the treatment. Blood samples will be taken at specific times to measure the amount of
drug in your body at specific times after the drug is given. Blood samples will also be taken
for lab tests such as complete blood counts and clinical chemistries. Physical exams will be
performed before each treatment. During the treatment phase, the patients will undergo
regular assessments for safety and clinical response.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00256880
Trial related presentations / publications
Prince HM, Honemann D, Spencer A, Rizzieri DA, Stadtmauer EA, Roberts AW, Bahlis N, Tricot G, Bell B, Demarini DJ, Benjamin Suttle A, Baker KL, Pandite LN. Vascular endothelial growth factor inhibition is not an effective therapeutic strategy for relapsed or refractory multiple myeloma: a phase 2 study of pazopanib (GW786034). Blood. 2009 May 7;113(19):4819-20. doi: 10.1182/blood-2009-02-207209. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00256880