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

NCT00427999 | Completed Phase 2 Results

• 2 other identifiers: CSTI571BDE592006-000218-19
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Hormone-refractory; prostate cancer; multitargeted; tyrosinkinase

Outcome Measures

Primary Outcomes (1)

• PSA Response Rate

  To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for \> 5 ng/ml.

  up to 24 weeks

Secondary Outcomes (4)

• Time to PSA Response

  every 4 weeks up to 24 weeks

• Time to Progression-free Survival

  every 4 weeks up to 24 weeks

• Overall Survival Rate

  every 4 weeks up to 24 weeks

• Quality of Life Assessed With EORTC-30

  baseline and Final Visit (week 24)

Study Arms (1)

STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

EXPERIMENTAL

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

Drug: imatinib mesylate; Drug: Treosulfane; Drug: etoricoxib; Drug: pioglitazone; Drug: dexamethasone

Interventions

imatinib mesylate DRUG

Also known as: Gleevec, Glivec

STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

Treosulfane DRUG

Also known as: Ovastat

STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

etoricoxib DRUG

Also known as: Arcoxia

STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

pioglitazone DRUG

Also known as: Actos

STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

dexamethasone DRUG

Also known as: Fortecortin

STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• Prior therapy with isotopes strontium or rhenium.
• Treatment with other experimental substances within 30 days before study start.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Bad Reichenhall, 83435, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hamburg, 22607, Germany

Location

Novartis Investigative Site

Kassel, 34131, Germany

Location

Novartis Investigative Site

Markkleeberg, 04416, Germany

Location

Novartis Investigative Site

Passau, 94032, Germany

Location

Novartis Investigative Site

Planegg, 82152, Germany

Location

Novartis Investigative Site

Regensburg, 93053, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Imatinib Mesylate; treosulfan; Etoricoxib; Pioglitazone; Dexamethasone; dexamethasone acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Sulfones; Sulfur Compounds; Pyridines; Thiazolidinediones; Thiazoles; Azoles; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 21, 2016
• Results First Posted: October 6, 2016

Record last verified: 2016-10

Locations

DE (10)