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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Docetaxel; Vadimezan

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