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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

approximately 2 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CASA404A2113

NCT ID:

NCT01299415

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Solid Tumors
  • ASA404,
  • Phase I,
  • Oncology,
  • CYP1A2,
  • fluvoxamine,
  • drug drug interaction,
  • Novartis,
  • Antisoma

Name

Location

Cancer Therapy & Research CenterSan Antonio, Texas  78229
Univ. of Indiana School of Medicine/Simon Cancer CenterIndianapolis, Indiana  46202
Masonic Cancer Center/ Clinical Trials OfficeMinneapolis, Minnesota  55455
Washington University School of Medicine/Siteman Cancer CenterSt. Louis, Missouri  63110