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

Novartis

Status and phase

Terminated

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: ASA404

Study type

Interventional

Funder types

Industry

Identifiers

NCT01299701

CASA404A2108

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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