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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


Phase 4
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane)

Outcome Time Frame:

every 4 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSTI571BDE59

NCT ID:

NCT00427999

Start Date:

February 2007

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Hormone-refractory
  • prostate cancer
  • multitargeted
  • tyrosinkinase
  • Prostatic Neoplasms

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