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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01278849




Registration number
NCT01278849
Ethics application status
Date submitted
17/01/2011
Date registered
19/01/2011
Date last updated
27/11/2012

Titles & IDs
Public title
An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function
Scientific title
A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of ASA404 in Adult Cancer Patients With Impaired Hepatic Function and With Normal Hepatic Function
Secondary ID [1] 0 0
EudraCT 2009-016471-30
Secondary ID [2] 0 0
CASA404A2105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Histologically-proven and Radiologically-confirmed Solid Tumors 0 0
Condition category
Condition code

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

Experimental: ASA404 + standard therpy -


Treatment: Drugs: ASA404


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

Outcomes
Primary outcome [1] 0 0
(Core Phase)To evaluate the PK of a single intravenous dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function compared to matching patients with normal hepatic function
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
To assess the safety and tolerability of a single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function as compared to controls with normal hepatic function
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
(Extension Phase) assess the safety & tolerability of ASA404 either alone or in combination with a sponsor approved taxane-based regimen in adult cancer patients with impaired hepatic function as compared to controls with normal hepatic function
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
To assess the safety of the combined regimen on the frequency and severity of adverse events and the number of laboratory values worsening from baseline based on the CTCAE grade assessment.
Timepoint [3] 0 0
18 months

Eligibility
Key inclusion criteria
- Patients having histologically-proven solid tumors, who are refractory to standard
chemotherapy;

- Patients whom chemotherapy with an investigational agent in combination with
docetaxel, or paclitaxel + carboplatin is appropriate;

- Age = 18 years old

- Creatinine clearance according to Cockcroft-Gault formula = 60 mL/min

- A minimum of 4 weeks must have elapsed since the last treatment with other cancer
therapies;

- Potassium, calcium, magnesium and phosphorus values within the normal range Total
bilirubin = 6 X ULN
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients having CNS metastases, must have a CT or MRI of the brain performed to rule
out CNS metastases;

- Patients with leptomeningeal disease metastases;

- Major surgery </ 4 weeks prior to the start of study;

- Prior exposure to VDAs or other vascular targeting agents;

- Right bundle branch block (RBBB), complete left bundle branch block (LBBB);

- Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14
days prior to starting study drug;

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
Parallel
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
Italy
State/province [1] 0 0
AN
Country [2] 0 0
Italy
State/province [2] 0 0
Milano
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

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 obtain pharmacokinetic data following a single-dose 20-minute i.v.
administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying
degrees of hepatic impairment. The study will be carried out in cancer volunteer patients
(utilizing controls with normal hepatic function) who will be assigned to four hepatic
impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study
will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a
single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired
hepatic function, and compared to controls with normal hepatic function. The assessments will
be done on the safety and tolerability of that single dose in adult cancer patients with
impaired hepatic function and compared to controls with normal hepatic function. The
Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same
three doses in combination with a sponsor-approved taxane-based regimen in adult cancer
patients with impaired hepatic function and compared to controls with normal hepatic
function.
Trial website
https://clinicaltrials.gov/show/NCT01278849
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Investigative Site
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/NCT01278849