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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00427999
First received: January 25, 2007
Last updated: October 6, 2016
Last verified: October 2016
  Purpose
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
Drug: Treosulfane
Drug: etoricoxib
Drug: pioglitazone
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: 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:
  • PSA Response Rate [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to PSA Response [ Time Frame: every 4 weeks up to 24 weeks ] [ Designated as safety issue: No ]
    Time to PSA response, defined as the time from first administration of study drugs to the first PSA value of a confirmed PSA response. Non-responders will be censored with date of final visit/premature discontinuation for the analysis. Median time to PSA response was not achieved

  • Time to Progression-free Survival [ Time Frame: every 4 weeks up to 24 weeks ] [ Designated as safety issue: No ]
    Progression-free survival, defined as the time from first administration of study drugs to the first PSA value of a PSA non-responder. Responders will be censored with date of PSA response for the analysis. The median time to PSA progression free survival was not achieved

  • Overall Survival Rate [ Time Frame: every 4 weeks up to 24 weeks ] [ Designated as safety issue: No ]
    Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. The median time to overall survival rate was not achieved

  • Quality of Life Assessed With EORTC-30 [ Time Frame: baseline and Final Visit (week 24) ] [ Designated as safety issue: No ]
    Health-related quality of life was assessed with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-30) questionnaire and was presented descriptively. The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.


Enrollment: 67
Study Start Date: February 2007
Study Completion Date: August 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane
STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
Drug: imatinib mesylate
Other Names:
  • Gleevec
  • Glivec
Drug: Treosulfane
Other Name: Ovastat
Drug: etoricoxib
Other Name: Arcoxia
Drug: pioglitazone
Other Name: Actos
Drug: dexamethasone
Other Name: Fortecortin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  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 ClinicalTrials.gov identifier: NCT00427999

Locations
Germany
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00427999     History of Changes
Other Study ID Numbers: CSTI571BDE59  2006-000218-19 
Study First Received: January 25, 2007
Results First Received: August 10, 2016
Last Updated: October 6, 2016
Health Authority: United States: Food and Drug Administration
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by Novartis:
Hormone-refractory
prostate cancer
multitargeted
tyrosinkinase

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Etoricoxib
Dexamethasone
Dexamethasone 21-phosphate
Imatinib Mesylate
Hormones
BB 1101
Pioglitazone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Hypoglycemic Agents

ClinicalTrials.gov processed this record on December 09, 2016