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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01285453

Enrollment

Registered

2011-01-28

Start date

2009-03-31

Completion date

Unknown

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Recurrent Solid Tumors

Keywords

ASA404,, vadimezan,, docetaxel

Brief summary

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

Interventions

DRUGvadimezan

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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/

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026