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

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced or Recurrent Solid Tumors

Treatments: Drug: vadimezan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01285453

CASA404A1102

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

ASA404

Experimental group

Treatment:

Drug: vadimezan