Back to resultsSafety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors
Primary Purpose
Advanced or Recurrent Solid Tumors
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
vadimezan
Sponsored by
About this trial
This is an interventional treatment trial for Advanced or Recurrent Solid Tumors focused on measuring ASA404,, vadimezan,, docetaxel
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASA404
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01285453
First Posted
January 26, 2011
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01285453
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Recurrent Solid Tumors
Keywords
ASA404,, vadimezan,, docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASA404
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vadimezan
Other Intervention Name(s)
ASA404
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Aichi
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21835825
Citation
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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4003
Description
Results for CASA404A1102 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors
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