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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
imatinib mesylate
Treosulfane
etoricoxib
pioglitazone
dexamethasone
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone-refractory, prostate cancer, multitargeted, tyrosinkinase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane

Arm 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

Outcomes

Primary Outcome Measures

PSA Response Rate
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 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
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
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
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.

Full Information

First Posted
January 25, 2007
Last Updated
October 6, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00427999
Brief Title
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer
Acronym
INV342
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hormone-refractory, prostate cancer, multitargeted, tyrosinkinase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
Gleevec, Glivec
Intervention Type
Drug
Intervention Name(s)
Treosulfane
Other Intervention Name(s)
Ovastat
Intervention Type
Drug
Intervention Name(s)
etoricoxib
Other Intervention Name(s)
Arcoxia
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
Actos
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Fortecortin
Primary Outcome Measure Information:
Title
PSA Response Rate
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.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Time to PSA Response
Description
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 Frame
every 4 weeks up to 24 weeks
Title
Time to Progression-free Survival
Description
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
Time Frame
every 4 weeks up to 24 weeks
Title
Overall Survival Rate
Description
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
Time Frame
every 4 weeks up to 24 weeks
Title
Quality of Life Assessed With EORTC-30
Description
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.
Time Frame
baseline and Final Visit (week 24)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bad Reichenhall
ZIP/Postal Code
83435
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novartis Investigative Site
City
Kassel
ZIP/Postal Code
34131
Country
Germany
Facility Name
Novartis Investigative Site
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Facility Name
Novartis Investigative Site
City
Passau
ZIP/Postal Code
94032
Country
Germany
Facility Name
Novartis Investigative Site
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Facility Name
Novartis Investigative Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Novartis Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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