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

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ClinicalTrials.gov Identifier: NCT01285453
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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
Study Start Date : March 2009
Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ASA404 Drug: vadimezan
Other Name: ASA404

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

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

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

Novartis Investigative Site
Aichi, Japan
Novartis Investigative Site
Osaka, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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 Posted: January 28, 2011    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

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