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

NCT01299415 | Terminated Phase 1

• 1 other identifier: CASA404A2113
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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.

Conditions

Solid Tumors

Keywords

ASA404,; Phase I,; Oncology,; CYP1A2,; fluvoxamine,; drug drug interaction,; Novartis,; Antisoma

Outcome Measures

Primary Outcomes (1)

• evaluate the effect of administration of fluvoxamine, a CYP1A2 inhibitor, after 2-cycles of ASA404, on the pharmacokinetics of ASA404

  approximately 2 months

Secondary Outcomes (2)

• evaluate the effect of administration of fluvoxamine on the safety profile (incidence of AEs or SAEs generated) of ASA404

  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

  12 months

Study Arms (1)

ASA404 + Fluvoxamine

EXPERIMENTAL

ASA404 + Fluvoxamine (Core Phase), ASA404 + either paclitaxel or docetaxel or paclitaxel plus carboplain chemotherapy combination (Extension Phase)

Drug: Vadimezan™

Interventions

Vadimezan™ DRUG

Also known as: ASA404

ASA404 + Fluvoxamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Univ. of Indiana School of Medicine/Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Masonic Cancer Center/ Clinical Trials Office

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine/Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Cancer Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

vadimezan

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 18, 2011
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Last Updated: September 2, 2011

Record last verified: 2011-08

Locations

US (4)