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Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285453
First Posted: January 28, 2011
Last Update Posted: November 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.

Condition Intervention Phase
Advanced or Recurrent Solid Tumors Drug: vadimezan Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Enrollment: 9
Study Start Date: March 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASA404 Drug: vadimezan
Other Name: ASA404

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285453


Locations
Japan
Novartis Investigative Site
Aichi, Japan
Novartis Investigative Site
Osaka, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01285453     History of Changes
Other Study ID Numbers: CASA404A1102
First Submitted: January 26, 2011
First Posted: January 28, 2011
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ASA404,
vadimezan,
docetaxel

Additional relevant MeSH terms:
Docetaxel
Vadimezan
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action