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

History of Changes

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:

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

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:

Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel
WHO Performance Status of 0-1

Exclusion Criteria:

Patients having symptomatic CNS tumor/metastasis and requiring treatment
Patients who have received prior therapy with ASA404 or other vascular disrupting agents
Patients with systolic BP > 160mmHg and/or diastolic BP > 90mmHg
Patients with fluid retention
Patients with any one of cardiotoxicities
Concomitant use of drugs with a risk of prolonging the QT interval
Known allergy or hypersensitivity to taxane or polysorbate 80

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Aug 10.

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 May 19, 2013

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