Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer (INV342)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 25, 2007
Last updated: January 3, 2015
Last verified: January 2015

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.

Condition Intervention Phase
Prostate Cancer
Drug: imatinib mesylate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to PSA response. [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: February 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane Drug: imatinib mesylate
Other Names:
  • Gleevec
  • Glivec


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00427999

Novartis Investigative Site
Bad Reichenhall, Germany, 83435
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hamburg, Germany, 22607
Novartis Investigative Site
Kassel, Germany, 34131
Novartis Investigative Site
Markkleeberg, Germany, 04416
Novartis Investigative Site
Passau, Germany, 94032
Novartis Investigative Site
Planegg, Germany, 82152
Novartis Investigative Site
Regensburg, Germany, 93053
Novartis Investigative Site
Tübingen, Germany, 72076
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT00427999     History of Changes
Other Study ID Numbers: CSTI571BDE59, 2006-000218-19
Study First Received: January 25, 2007
Last Updated: January 3, 2015
Health Authority: United States: Food and Drug Administration
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by Novartis:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on March 03, 2015