Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer (INV342)

Novartis

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00427999

CSTI571BDE59

2006-000218-19

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

Experimental group

Description:

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

Treatment:

Drug: etoricoxib

Drug: pioglitazone

Drug: Treosulfane

Drug: dexamethasone

Drug: imatinib mesylate