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

Prostate Cancer Clinical Trial

— INV342  

Official title:

A Single Stage Phase II, Multi-centre, Open Label Study of Imatinib in Combination With Pioglitazone, Etoricoxib, Dexamethasone and Low-dose Treosulfane for Anti-inflammatory and Angiostatic Treatment in Patients With Hormone-refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427999
• Other study ID #: CSTI571BDE59
• Secondary ID: 2006-000218-19
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2007
• Last updated: March 5, 2016
• Start date: February 2007
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bad Reichenhall
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Markkleeberg
Germany	Novartis Investigative Site	Passau
Germany	Novartis Investigative Site	Planegg
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane)		every 4 weeks	No
Secondary	Time to PSA response.		every 4 weeks	No