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

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: ASA404

• Registration Number: NCT01299701
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASA404	ASA404	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
determine the rate and routes of excretion of ASA404 (60 µCi)	12 months
collect safety data (including electrocardiograms) for ASA404	12 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇳🇿 Grafton, Auckland, New Zealand