NCT01285453

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
Last Updated

December 9, 2020

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

January 26, 2011

Last Update Submit

December 6, 2020

Conditions

Advanced or Recurrent Solid Tumors

Keywords

ASA404,vadimezan,docetaxel

Study Arms (1)

ASA404

EXPERIMENTAL
Drug: vadimezan

Interventions

vadimezanDRUG
Also known as: ASA404
ASA404

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel
  • WHO Performance Status of 0-1

You may not qualify if:

  • Patients having symptomatic CNS tumor/metastasis and requiring treatment
  • Patients who have received prior therapy with ASA404 or other vascular disrupting agents
  • Patients with systolic BP \> 160mmHg and/or diastolic BP \> 90mmHg
  • Patients with fluid retention
  • Patients with any one of cardiotoxicities
  • Concomitant use of drugs with a risk of prolonging the QT interval
  • Known allergy or hypersensitivity to taxane or polysorbate 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Aichi, Japan

Location

Novartis Investigative Site

Osaka, Japan

Location

Related Publications (1)

  • Daga H, Hida T, Ishikawa S, Shimizu J, Tokunaga S, Horio Y, Kobayashi K, Takeda K. The safety and tolerability of intravenous ASA404 when administered in combination with docetaxel (60 or 75 mg/m(2)) in Japanese patients with advanced or recurrent solid tumors. Jpn J Clin Oncol. 2011 Sep;41(9):1067-73. doi: 10.1093/jjco/hyr110. Epub 2011 Aug 10.

    PMID: 21835825DERIVED

Related Links

MeSH Terms

Interventions

vadimezan

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 28, 2011

Study Start

March 1, 2009

Primary Completion

December 1, 2009

Last Updated

December 9, 2020

Record last verified: 2012-11

Locations

JP(2)