 |
|
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-Refractory Prostate Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
Phase II
|
|
|
|
Treatment
|
|
|
|
Active
|
|
|
|
18 and over
|
|
|
|
Pharmaceutical / Industry
|
|
|
|
CSTI571BDE59
NCT00427999
|
|
|
Trial Description
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 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
- 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 Contact Information
Trial Lead Organizations/Sponsors Novartis Pharmaceuticals Corporation | Novartis | | Study Chair |
| Novartis Basel | | Ph: 41 61 324 1111 |
Trial Sites
|
|
|
|
| Germany |
|
| |
Regensburg |
|
| | | | | | | | Study Site |
|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00427999
Information obtained from ClinicalTrials.gov on July 23, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
Back to Top |
 |
