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

NCT ID: NCT01285453

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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

Detailed Description

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Conditions

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Advanced or Recurrent Solid Tumors

Keywords

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ASA404, vadimezan, docetaxel

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASA404

Group Type EXPERIMENTAL

vadimezan

Intervention Type DRUG

Interventions

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vadimezan

Intervention Type DRUG

Other Intervention Names

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ASA404

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Aichi, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 21835825 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4003

Results for CASA404A1102 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CASA404A1102

Identifier Type: -

Identifier Source: org_study_id