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A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors


Phase 1
20 Years
N/A
Not Enrolling
Both
Advanced or Recurrent Solid Tumors

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Trial Information

A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors


Inclusion Criteria:



1. Patients with confirmed solid tumors whose disease has progressed or recurred after
treatment at lease one therapy, except docetaxel

2. WHO Performance Status of 0-1

Exclusion Criteria:

1. Patients having symptomatic CNS tumor/metastasis and requiring treatment

2. Patients who have received prior therapy with ASA404 or other vascular disrupting
agents

3. Patients with systolic BP > 160mmHg and/or diastolic BP > 90mmHg

4. Patients with fluid retention

5. Patients with any one of cardiotoxicities

6. Concomitant use of drugs with a risk of prolonging the QT interval

7. Known allergy or hypersensitivity to taxane or polysorbate 80

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

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CASA404A1102

NCT ID:

NCT01285453

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Advanced or Recurrent Solid Tumors
  • ASA404,
  • vadimezan,
  • docetaxel
  • Neoplasms

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