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

NCT ID: NCT01299415

Last Updated: 2011-09-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASA404 + Fluvoxamine

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

Group Type: EXPERIMENTAL

Vadimezan™

Intervention Type: DRUG

Interventions

Vadimezan™

Intervention Type: DRUG

Other Intervention Names

ASA404

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Univ. of Indiana School of Medicine/Simon Cancer Center

Indianapolis, Indiana, United States

Masonic Cancer Center/ Clinical Trials Office

Minneapolis, Minnesota, United States

Washington University School of Medicine/Siteman Cancer Center

St Louis, Missouri, United States

Cancer Therapy & Research Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

CASA404A2113

Identifier Type: -

Identifier Source: org_study_id