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
  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: 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:

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01285453     History of Changes
Other Study ID Numbers: CASA404A1102
Study First Received: January 26, 2011
Last Updated: November 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
ASA404,
vadimezan,
docetaxel

Additional relevant MeSH terms:
Neoplasms
5,6-dimethylxanthenoneacetic acid
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014