Phase 2
N=65
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00427999 ↗Enrolled (actual)
65
Serious AEs
34.5%
Results posted
Oct 2016
Primary outcome: Primary: PSA Response Rate — 38; 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- imatinib mesylate (Drug); Treosulfane (Drug); etoricoxib (Drug); pioglitazone (Drug); dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PSA Response Rate |
38; 23 | — |
| SECONDARY Time to PSA Response |
NA | — |
| SECONDARY Time to Progression-free Survival |
NA | — |
| SECONDARY Overall Survival Rate |
NA | — |
| SECONDARY Quality of Life Assessed With EORTC-30 |
11.6; 16.0; 20.4; 14.0; 74.0; 34.0 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT00427999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.