Status:
COMPLETED
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00427999
Start Date
February 1 2007
End Date
August 1 2015
Last Update
November 21 2016
Active Locations (10)
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1
Novartis Investigative Site
Bad Reichenhall, Germany, 83435
2
Novartis Investigative Site
Bonn, Germany, 53105
3
Novartis Investigative Site
Hamburg, Germany, 20246
4
Novartis Investigative Site
Hamburg, Germany, 22607