A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors

Advanced Solid Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01299701
• Other study ID #: CASA404A2108
• Status: Terminated
• Phase: Phase 1
• First received: February 10, 2011
• Last updated: February 13, 2017
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• ASA404
(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA

Locations

Country	Name	City	State
New Zealand	Novartis Investigative Site	Grafton, Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		12 months
Secondary	determine the rate and routes of excretion of ASA404 (60 µCi)		12 months
Secondary	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		12 months
Secondary	collect safety data (including electrocardiograms) for ASA404		12 months