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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01299415
First received: January 26, 2011
Last updated: August 31, 2011
Last verified: August 2011
  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: 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:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01299415     History of Changes
Other Study ID Numbers: CASA404A2113
Study First Received: January 26, 2011
Last Updated: August 31, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Fluvoxamine
Vadimezan
Anti-Anxiety Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antineoplastic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014