Safety and Pharmacokinetics of ASA404 When Given Together With Fluvoxamine, a Selective Serotonin Receptor Reuptake Inhibitor and CYP1A2 Inhibitor
This study has been terminated.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: January 26, 2011
Last updated: August 31, 2011
Last verified: August 2011
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Primary Completion Date:
||September 2010 (Final data collection date for primary outcome measure)
Experimental: ASA404 + Fluvoxamine
ASA404 + Fluvoxamine (Core Phase), ASA404 + either paclitaxel or docetaxel or paclitaxel plus carboplain chemotherapy combination (Extension Phase)
Other Name: ASA404
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients having a histologically-proven and radiologically-confirmed advanced or metastatic solid tumor.
- WHO Performance Status of 0-2.
- A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies.
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
- Patients having CNS metastasis or evidence of leptomeningeal disease.
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
- History of neuroendocrine tumors (e.g. carcinoid tumor, pancreatic islet cell tumor).
- Significant neurological or psychiatric disorder.
- Smokers (use of cigarettes within the last 3 months).
- Concomitant use of drugs that are associated with QTc interval prolongation or have a risk of causing torsade de pointes.
- 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.
- 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
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
|Univ. of Indiana School of Medicine/Simon Cancer Center
|Indianapolis, Indiana, United States, 46202 |
|Masonic Cancer Center/ Clinical Trials Office
|Minneapolis, Minnesota, United States, 55455 |
|Washington University School of Medicine/Siteman Cancer Center
|St. Louis, Missouri, United States, 63110 |
|Cancer Therapy & Research Center
|San Antonio, Texas, United States, 78229 |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 26, 2011
||August 31, 2011
||United States: Food and Drug Administration
Keywords provided by Novartis:
drug drug interaction,
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 25, 2014
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation