---
title: Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors
nct_id: NCT01285453
overall_status: COMPLETED
phase: PHASE1
sponsor: Novartis Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Advanced or Recurrent Solid Tumors
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01285453.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01285453"
ct_last_update_post_date: 2020-12-09
last_seen_at: "2026-05-12T07:11:25.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors

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

**NCT ID:** [NCT01285453](https://clinicaltrials.gov/study/NCT01285453)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** Novartis Pharmaceuticals
- **Conditions:** Advanced or Recurrent Solid Tumors
- **Start Date:** 2009-03
- **CT.gov Last Update:** 2020-12-09

## Brief Summary

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

## Eligibility

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **ASA404** (EXPERIMENTAL)

## Interventions

- **vadimezan** (DRUG)

## Locations (2)

- Novartis Investigative Site, Aichi, Japan
- Novartis Investigative Site, Osaka, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.novartis investigative site|aichi||japan` — added _(2026-05-12)_
- `locations.novartis investigative site|osaka||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01285453.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01285453*  
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