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 completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01299701
First received: February 10, 2011
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • determine the rate and routes of excretion of ASA404 (60 µCi) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • collect safety data (including electrocardiograms) for ASA404 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: December 2008
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299701

Locations
New Zealand
University of Auckland/Faculty of Medical and Health Sciences
Auckland, New Zealand, 1023
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Investigative
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01299701     History of Changes
Other Study ID Numbers: CASA404A2108
Study First Received: February 10, 2011
Last Updated: August 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Advanced or metastatic cancer
refractory
core phase
extension phase
dose escalation
standard chemotherapy
docetaxel
paclitaxel
carboplatin
safety
tolerability

Additional relevant MeSH terms:
Neoplasms
5,6-dimethylxanthenoneacetic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014