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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01285453
First received: January 26, 2011
Last updated: November 26, 2012
Last verified: November 2012

January 26, 2011
November 26, 2012
March 2009
December 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01285453 on ClinicalTrials.gov Archive Site
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Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors
A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors

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

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced or Recurrent Solid Tumors
Drug: vadimezan
Other Name: ASA404
Experimental: ASA404
Intervention: Drug: vadimezan
Daga H, Hida T, Ishikawa S, Shimizu J, Tokunaga S, Horio Y, Kobayashi K, Takeda K. The safety and tolerability of intravenous ASA404 when administered in combination with docetaxel (60 or 75 mg/m²) in Japanese patients with advanced or recurrent solid tumors. Jpn J Clin Oncol. 2011 Sep;41(9):1067-73. doi: 10.1093/jjco/hyr110. Epub 2011 Aug 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
Not Provided
December 2009   (final data collection date for primary outcome measure)

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

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01285453
CASA404A1102
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP