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

NCT ID: NCT01299701

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-07-31

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASA404

Group Type: EXPERIMENTAL

ASA404

Intervention Type: DRUG

(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA

Interventions

ASA404

(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Investigative

Locations

Novartis Investigative Site

Grafton, Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

CASA404A2108

Identifier Type: -

Identifier Source: org_study_id