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

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: NCT01299415
Recruitment Status : Terminated
First Posted : February 18, 2011
Last Update Posted : September 2, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Drug: Vadimezan™ Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
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
Study Start Date : August 2009
Actual Primary Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. evaluate the effect of administration of fluvoxamine on the safety profile (incidence of AEs or SAEs generated) of ASA404 [ Time Frame: 4 months ]
  2. 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 ]

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:

  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

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): NCT01299415

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01299415    
Other Study ID Numbers: CASA404A2113
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Phase I,
drug drug interaction,
Additional relevant MeSH terms:
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Antineoplastic Agents