Skip to main content
OpenTrials
Completed

NCT Number: NCT01285453

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced or Recurrent Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vadimezan

Drug

Other names: ASA404

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors

Important dates

Study start
2009
Primary completion
2009
First posted
Jan 28, 2011
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.