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

Advanced or Recurrent Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285453
• Other study ID #: CASA404A1102
• Status: Completed
• Phase: Phase 1
• Start date: March 2009

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced or Recurrent Solid Tumors
• Neoplasms

Intervention

Drug:
• vadimezan

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Aichi
Japan	Novartis Investigative Site	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

External Links

•   Results for CASA404A1102 can be found on the Novartis Clinical Trial Results Website