Clinical trial · Interventional
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer
A Single Stage Phase II, Multi-centre, Open Label Study of Imatinib in Combination With Pioglitazone, Etoricoxib, Dexamethasone and Low-dose Treosulfane for Anti-inflammatory and Angiostatic Treatment in Patients With Hormone-refractory Prostate Cancer
NCT00427999CI-TRIAL-00024855INV342completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoricoxib | Drug | — | UNRESOLVED |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| pioglitazone | Drug | — | UNRESOLVED |
| Treosulfane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane
- 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
- interventionNames
- Drug: imatinib mesylate
- Drug: Treosulfane
- Drug: etoricoxib
- Drug: pioglitazone
- Drug: dexamethasone
Primary outcomes (1)
- measure
- PSA Response Rate
- timeFrame
- up to 24 weeks
- description
- To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for \> 5 ng/ml.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.