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Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer

NCT ID: NCT00427999

Last Updated: 2016-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to evaluate the efficacy, tolerability and safety of a multi-targeted therapy in patients with hormone-refractory prostate cancer.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Hormone-refractory prostate cancer multitargeted tyrosinkinase

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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STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Group Type EXPERIMENTAL

imatinib mesylate

Intervention Type DRUG

Treosulfane

Intervention Type DRUG

etoricoxib

Intervention Type DRUG

pioglitazone

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

Interventions

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imatinib mesylate

Intervention Type DRUG

Treosulfane

Intervention Type DRUG

etoricoxib

Intervention Type DRUG

pioglitazone

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

Other Intervention Names

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Gleevec Glivec Ovastat Arcoxia Actos Fortecortin

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed prostate carcinoma, which has proven progression after primary hormone therapy (surgical or medicinal castration).
* Patients must have increasing PSA levels (within 3 months prior to enrollment) with at least two consecutively increasing PSA levels.
* PSA value before inclusion must be at least 5 ng/ml
* At least 18 years of age.
* At least capable of self care and up of at least 50% of waking hours (ECOG performance status 0 - 2), adequate bone marrow function and lab results.

Exclusion Criteria

* Change of hormone therapy within 6 weeks prior inclusion
* Prior chemotherapy
* Therapy with Imatinib, or therapy with other inhibitors of tyrosinkinase.
* Second neoplasm diagnosed within 5 years before study start.
* Patients who require therapy with warfarin
* Known diagnosis of HIV, hepatitis B, or hepatitis C infection.
* Severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including severe cardiac insufficiency
* Surgical therapy within 4 weeks before inclusion.
* Prior therapy with isotopes strontium or rhenium.
* Radiation therapy to \> 25% of bone marrow within 4 weeks before inclusion.
* Treatment with other experimental substances within 30 days before study start.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

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

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Bad Reichenhall, , Germany

Site Status

Novartis Investigative Site

Bonn, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Kassel, , Germany

Site Status

Novartis Investigative Site

Markkleeberg, , Germany

Site Status

Novartis Investigative Site

Passau, , Germany

Site Status

Novartis Investigative Site

Planegg, , Germany

Site Status

Novartis Investigative Site

Regensburg, , Germany

Site Status

Novartis Investigative Site

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2006-000218-19

Identifier Type: -

Identifier Source: secondary_id

CSTI571BDE59

Identifier Type: -

Identifier Source: org_study_id