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Safety and Pharmacokinetics of ASA404 When Given Together With Fluvoxamine, a Selective Serotonin Receptor Reuptake Inhibitor and CYP1A2 Inhibitor

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01299415
First Posted: February 18, 2011
Last Update Posted: September 2, 2011
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and ASA404. The purpose of the Extension Phase is to provide continued treatment for those patients that have not progressed during the Core Phase and to collect safety data on ASA404 when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin chemotherapy regimen.

Condition Intervention Phase
Solid Tumors Drug: Vadimezan™ Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effects of Fluvoxamine on the Pharmacokinetics of ASA404 in Adult Patients With Solid Tumor Malignancies

Resource links provided by NLM:


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

Primary Outcome Measures:
  • evaluate the effect of administration of fluvoxamine, a CYP1A2 inhibitor, after 2-cycles of ASA404, on the pharmacokinetics of ASA404 [ Time Frame: approximately 2 months ]

Secondary Outcome Measures:
  • evaluate the effect of administration of fluvoxamine on the safety profile (incidence of AEs or SAEs generated) of ASA404 [ Time Frame: 4 months ]
  • assess the safety (incidence of AEs and SAEs) of ASA404 in combination with paclitaxel, doctaxel or the paclitaxel plus carboplatin chemotherapy regimen in patients with solid tumor malignancies [ Time Frame: 12 months ]

Enrollment: 17
Study Start Date: August 2009
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASA404 + Fluvoxamine
ASA404 + Fluvoxamine (Core Phase), ASA404 + either paclitaxel or docetaxel or paclitaxel plus carboplain chemotherapy combination (Extension Phase)
Drug: Vadimezan™
Other Name: ASA404

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients having a histologically-proven and radiologically-confirmed advanced or metastatic solid tumor.
  2. WHO Performance Status of 0-2.
  3. A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies.
  4. Laboratory values within the ranges, as defined below:

    • ANC ≥ 1.5 X 109 /L
    • Platelets ≥ 100 X 109 /L
    • Hemoglobin ≥ 10 g/dL
    • Serum total bilirubin is within normal range

Exclusion Criteria:

  1. Patients having CNS metastasis or evidence of leptomeningeal disease.
  2. Patients with any of the following:

    • any clinical or electrocardiographic evidence of cadiac ischemia
    • poorly controlled hypertension
    • family history of unexplained sudden death
    • long QT syndrome
    • history of ventricular fibrillation or torsade de pointes
    • congestive heart failure (NYHA class III or IV)
    • myocardial infarction within 12 months of starting study treatment
  3. History of neuroendocrine tumors (e.g. carcinoid tumor, pancreatic islet cell tumor).
  4. Significant neurological or psychiatric disorder.
  5. Smokers (use of cigarettes within the last 3 months).
  6. Concomitant use of drugs that are associated with QTc interval prolongation or have a risk of causing torsade de pointes.
  7. Concomitant use of serotonin reuptake inhibitors (SSRIs), 5-hydroxytryptamine (5-HT) receptor agonists or selective serotonin / nor-epinephrine reuptake inhibitors (SNRIs) within 30 days prior to starting study treatment.
  8. Concomitant use of somatostain analogues (i.e. octreotide, lanreotide within 30 days prior to starting study treatment.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01299415


Locations
United States, Indiana
Univ. of Indiana School of Medicine/Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Masonic Cancer Center/ Clinical Trials Office
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine/Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Texas
Cancer Therapy & Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01299415     History of Changes
Other Study ID Numbers: CASA404A2113
First Submitted: January 26, 2011
First Posted: February 18, 2011
Last Update Posted: September 2, 2011
Last Verified: August 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ASA404,
Phase I,
Oncology,
CYP1A2,
fluvoxamine,
drug drug interaction,
Novartis,
Antisoma

Additional relevant MeSH terms:
Fluvoxamine
Vadimezan
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Antineoplastic Agents