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Prostate CancerPhase 2INV342NCT00427999

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

A Phase 2 study testing imatinib mesylate, Treosulfane and etoricoxib in people with Prostate Cancer, run by Novartis Pharmaceuticals at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
imatinib mesylate, Treosulfane and etoricoxib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
10 sitesGermany
Study dates
Feb 2007to Aug 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Novartis Investigative Site

    Bad Reichenhall, 83435

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hamburg, 22607

  • Novartis Investigative Site

    Kassel, 34131

  • Novartis Investigative Site

    Markkleeberg, 04416

  • Novartis Investigative Site

    Passau, 94032

  • Novartis Investigative Site

    Planegg, 82152

  • Novartis Investigative Site

    Regensburg, 93053

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

About this study

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

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
Prostate Cancer
Being tested
imatinib mesylate, Treosulfane, etoricoxib, pioglitazone, dexamethasone
Keywords
Hormone-refractory, prostate cancer, multitargeted, tyrosinkinase
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    Also called Gleevec, Glivec

  • TreosulfaneDrug

    Also called Ovastat

  • etoricoxibDrug

    Also called Arcoxia

  • pioglitazoneDrug

    Also called Actos

  • dexamethasoneDrug

    Also called Fortecortin

Study groups in NCT00427999
Study groupRoleWhat they receive
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfaneExperimentalSTI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
Receives: Drug: imatinib mesylate; Drug: Treosulfane; Drug: etoricoxib; Drug: pioglitazone; Drug: dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 24 weeks

Secondary outcomes (4)

  1. 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

    Measured: every 4 weeks up to 24 weeks

  2. 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

    Measured: every 4 weeks up to 24 weeks

  3. 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

    Measured: every 4 weeks up to 24 weeks

  4. 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.

    Measured: baseline and Final Visit (week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionJun 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00427999
Sponsor's protocol ID
CSTI571BDE59
Other IDs
2006-000218-19
Acronym
INV342
Status last verified
Oct 2016
First submitted
25 Jan 2007
Last updated
21 Nov 2016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate, Treosulfane and etoricoxib in people with Prostate Cancer, run by Novartis Pharmaceuticals at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA Response Rate (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00427999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.

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