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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01299701
Recruitment Status : Terminated
First Posted : February 18, 2011
Last Update Posted : February 14, 2017
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: ASA404 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
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
Study Start Date : December 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: ASA404 Drug: ASA404
(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA

Primary Outcome Measures :
  1. 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 :
  1. determine the rate and routes of excretion of ASA404 (60 µCi) [ Time Frame: 12 months ]
  2. 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 ]
  3. collect safety data (including electrocardiograms) for ASA404 [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01299701

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New Zealand
Novartis Investigative Site
Grafton, Auckland, New Zealand
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Investigative
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01299701    
Other Study ID Numbers: CASA404A2108
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced or metastatic cancer
core phase
extension phase
dose escalation
standard chemotherapy
Additional relevant MeSH terms:
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Antineoplastic Agents