Prostatic NeoplasmPhase 2NCT01316458
Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy
A Phase 2 study testing STI571 (Glivec®) in people with Prostatic Neoplasm and Genital Neoplasms, Male, run by Novartis Pharmaceuticals at 13 sites in Germany.
Trial summary
To investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm, Genital Neoplasms, Male, Neoplasms, Abdominal
- What is being tested?
- STI571 (Glivec®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 13 sitesGermany
- Study dates
- Jun 2003to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- who are 18 years of age or older.
- who have undergone radical prostatectomy within 2 years prior to PSA progression .
- exhibiting two consecutive rises in PSA levels relative to a previous reference value, separated by 14 days.
- The first measurement must occur 14 days after the reference value und must be at least 20% above the reference value. The reference value must be at least 0.4 ng/ml. The second confirmatory measurement taken 14 days after the first measurement must be greater than the first measurement.
- with a Karnofsky Performance Score (KPS) greater than or equal to 90 (Appendix 5).
- with the following hematologic lab values: ANC greater than or equal to 1500/mm3, Hgb greater than or equal to 10g/dL, PLT greater than or equal to 100x109/L.
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- with the following biochemistry lab values: total bilirubin < 1.5 ULN, SGOT, SGPT less than or equal to 2.5 ULN, serum creatinine less than or equal to 1.5 ULN.
- willing to employ an effective barrier method of contraception during the study duration and for 3 months following discontinuation of study drug (for patients of reproductive potential).
- with a life expectancy of > 6 months.
- who have provided written informed consent pursuant to local regulatory requirements prior to initiation of any study procedure.
- with a Gleason Score > 6 in the prostatectomy specimen
Who cannot join
- with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer, unless written approval is obtained by the sponsor.
- with prior hormonal therapy
- who require therapy with warfarin or analgesics of the morphine class or higher (see Section 3.4.4).
- with a known diagnosis of HIV, hepatitis B, or hepatitis C infection.
- who have had a major surgery within 2 weeks prior to study entry.
- with severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including severe cardiac insufficiency (NYHA III or IV, see Appendix 2), uncontrolled diabetes, chronic hepatic or renal disease, and active uncontrolled infection.
- with a history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Novartis Investigative Site
Aachen
Novarts Investigative Site
Berlin
Novartis Investigative Site
Bonn
Novartis Investigative Site
Borken
Novartis Investigative Site
Cologne
Novartis Investigative Site
Darmstadt
Novartis Investigative Site
Fürth
Novartis Investigative Site
Gardelegen
Novarts Investigative Site
Hamburg
Novartis Investigative Site
Marburg
Novartis Investigative Site
Ulm
Novartis Investigative Site
Wesel
Novartis Investigative Site
Wuppertal
About this study
Official title: An Open-label, Multicenter, Phase II Study to Evaluate the Ability of Glivec® (Imatinib, Formerly Known as STI571) to Produce a Biochemical Response in Patients With Rising PSA Following Radical Prostatectomy
To investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment.
- Conditions
- Prostatic Neoplasm, Genital Neoplasms, Male, Neoplasms, Abdominal, Urogenital Neoplasms, Genital Diseases, Male, Prostatic Diseases
- Being tested
- STI571 (Glivec®)
- Keywords
- Prostate cancer,, radical prostatectomy,, PSA rise
- Medical subject headings
- Prostatic Neoplasms, Genital Neoplasms, Male, Abdominal Neoplasms, Urogenital Neoplasms, Genital Diseases, Male, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI571 (Glivec®)Drug
Also called Glivec
| Study group | Role | What they receive |
|---|---|---|
| imatinib mesylate | Experimental | Not described Receives: Drug: STI571 (Glivec®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment.
Measured: 2 - 4 weeks
Secondary outcomes (5)
investigate the time to sustained biochemical response under the treatment of Glivec® in this patient population
Measured: continuous
investigate duration of biochemical sustained response under the treatment with Glivec® in this patient population.
Measured: continuous
To assess the response rates: number of patients with complete, partial and minor biochemical response and stable PSA
Measured: continuous
To assess the time to clinical progression of this patient population treated with Glivec® at this dose and schedule.
Measured: continuous
To descriptively characterize the safety and tolerability of Glivec® administered at this dose and schedule to this patient population.
Measured: continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJun 2003
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316458
- Sponsor's protocol ID
- CSTI571BDE15
- Status last verified
- Mar 2011
- First submitted
- 14 Mar 2011
- Last updated
- 1 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase II Study to Evaluate the Ability of Glivec® (Imatinib, Formerly Known as STI571) to Produce a Biochemical Response in Patients With Rising PSA Following Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01316458
- Acronym / sponsor ID
- CSTI571BDE15
- Conditions
- Prostatic Neoplasm, Genital Neoplasms, Male, Neoplasms, Abdominal, Urogenital Neoplasms, Genital Diseases, Male, Prostatic Diseases
- Keywords
- Prostate cancer,, radical prostatectomy,, PSA rise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jul 2010 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imatinib mesylate | Experimental | Drug: STI571 (Glivec®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- who are 18 years of age or older.
- who have undergone radical prostatectomy within 2 years prior to PSA progression .
- exhibiting two consecutive rises in PSA levels relative to a previous reference value, separated by 14 days.
- The first measurement must occur 14 days after the reference value und must be at least 20% above the reference value. The reference value must be at least 0.4 ng/ml. The second confirmatory measurement taken 14 days after the first measurement must be greater than the first measurement.
- with a Karnofsky Performance Score (KPS) greater than or equal to 90 (Appendix 5).
Key exclusion criteria (8 listed)
- with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer, unless written approval is obtained by the sponsor.
- with prior hormonal therapy
- who require therapy with warfarin or analgesics of the morphine class or higher (see Section 3.4.4).
- with a known diagnosis of HIV, hepatitis B, or hepatitis C infection.
- who have had a major surgery within 2 weeks prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STI571 (Glivec®)Also: Glivec | Drug | imatinib mesylate |
Primary outcome
investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment.
Time frame: 2 - 4 weeks
5 secondary outcomes
investigate the time to sustained biochemical response under the treatment of Glivec® in this patient population
Time frame: continuous
investigate duration of biochemical sustained response under the treatment with Glivec® in this patient population.
Time frame: continuous
To assess the response rates: number of patients with complete, partial and minor biochemical response and stable PSA
Time frame: continuous
To assess the time to clinical progression of this patient population treated with Glivec® at this dose and schedule.
Time frame: continuous
To descriptively characterize the safety and tolerability of Glivec® administered at this dose and schedule to this patient population.
Time frame: continuous
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STI571 (Glivec®) in people with Prostatic Neoplasm and Genital Neoplasms, Male, run by Novartis Pharmaceuticals at 13 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 11 inclusion and 8 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
investigate the ability of 600 mg of Glivec®, given once daily by mouth to patients with rising PSA following radical prostatectomy, to produce a sustained biochemical response during the first 6 months of treatment. (time frame: 2 - 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2017.