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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoricoxib; Hormones; Imatinib Mesylate; Pioglitazone

Criteria

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