The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01299701




Registration number
NCT01299701
Ethics application status
Date submitted
10/02/2011
Date registered
18/02/2011
Date last updated
14/02/2017

Titles & IDs
Public title
A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors
Scientific title
An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Excretion (ADME) of ASA404 After a Single Intravenous Infusion of 3000 mg [14C]ASA404 in Patients With Advanced Solid Tumor Malignancies
Secondary ID [1] 0 0
CASA404A2108
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ASA404

Experimental: ASA404 -


Treatment: Drugs: ASA404
(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA

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

Outcomes
Primary outcome [1] 0 0
characterize the pharmacokinetic profiles of ASA404 and any potential metabolite(s) in plasma and pharmacokinetic profiles of the total radioactivity in blood and plasma after a single intravenous infusion of 3000 mg [14C] ASA404 (60 µCi)
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
determine the rate and routes of excretion of ASA404 (60 µCi)
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
identify metabolite(s) structures(s) and quantify the metabolites of ASA404 in plasma, urine, and feces in order to elucidate the biotransformation pathways and determine the essential clearance mechanisms of ASA404
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
collect safety data (including electrocardiograms) for ASA404
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
- Histologically proven diagnosis of advanced or metastatic solid tumors for whom either
refractory to standard therapy exists, or for whom treatment with an investigational
agent alone or in combination with docetaxel, paclitaxel, carboplatin, or paclitaxel
plus carboplatin is appropriate;

- ANC= 1.5 x 109/L;

- Hgb = 9.0 g/L;

- PLT = 100,000/mm3;

- Total bilirubin = 1.5;

- Willing and able to remain in the clinic for at least 4 days
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with CNS and/or leptomeningeal disease metastases allowed on the study unless
asymptomatic and not requiring corticosteroid therapy. Patients having any clinical
signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS
metastases in order to be eligible for study participation. Patients who have had
brain metastases surgically removed or irradiated with no residual disease confirmed
by imaging are allowed;

- Patients unable to undergo intravenous infusion;

- Patients with a Baseline 12-lead EGC QTc of >450 msec;

- Radiotherapy in less than two (2) weeks prior to study entry;

- A history of noncompliance to medical regimens or inability or unwillingness to return
for all scheduled visits

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Grafton, Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to characterize the absorption, distribution, metabolism and excretion
(ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800
mg/m2) ASA404 containing 60 µCi of 14C over a period of 20 minutes in patients with advanced
solid tumors. Metabolic pathways, route (s) of elimination, distribution characteristics in
plasma and blood, and exposure characterization in plasma and blood, and exposure
characterization of the parent drug and metabolites will be obtained from the study.
Trial website
https://clinicaltrials.gov/show/NCT01299701
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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/show/NCT01299701