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

This study has been terminated.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: February 10, 2011
Last updated: February 13, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Advanced Solid Tumors Drug: ASA404 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • determine the rate and routes of excretion of ASA404 (60 µCi) [ Time Frame: 12 months ]
  • 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 [ Time Frame: 12 months ]
  • collect safety data (including electrocardiograms) for ASA404 [ Time Frame: 12 months ]

Enrollment: 7
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASA404 Drug: ASA404
(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01299701

New Zealand
Novartis Investigative Site
Grafton, Auckland, New Zealand
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Investigative
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01299701     History of Changes
Other Study ID Numbers: CASA404A2108
Study First Received: February 10, 2011
Last Updated: February 13, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced or metastatic cancer
core phase
extension phase
dose escalation
standard chemotherapy

Additional relevant MeSH terms:
Antineoplastic Agents processed this record on September 21, 2017