Safety and Tolerability of ASA404 Administered in Combina... | NCT01285453

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

NCT01285453

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 9, 2020Actual

Enrollment

9Actual

Phase

Phase 1

Conditions

Advanced or Recurrent Solid Tumors

Interventions

vadimezan

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Not provided

First Submitted Date

Jan 26, 2011

First Submission Date that Met QC Criteria

Jan 26, 2011

First Posted Date

Jan 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2020

Last Update Posted Date

Dec 9, 2020Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
ASA404	Experimental		Drug: vadimezan

Name	Type	Description	Arm Group Labels	Other Names
vadimezan	Drug		ASA404	ASA404

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Aichi			Japan
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21835825	Derived	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.