Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy
Primary Purpose
Prostatic Neoplasm, Genital Neoplasms, Male, Neoplasms, Abdominal
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
STI571 (Glivec®)
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasm focused on measuring Prostate cancer,, radical prostatectomy,, PSA rise
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Novartis Investigative Site
- Novarts Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novarts 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
imatinib mesylate
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
investigate the time to sustained biochemical response under the treatment of Glivec® in this patient population
investigate duration of biochemical sustained response under the treatment with Glivec® in this patient population.
To assess the response rates: number of patients with complete, partial and minor biochemical response and stable PSA
To assess the time to clinical progression of this patient population treated with Glivec® at this dose and schedule.
To descriptively characterize the safety and tolerability of Glivec® administered at this dose and schedule to this patient population.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01316458
Brief Title
Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm, Genital Neoplasms, Male, Neoplasms, Abdominal, Urogenital Neoplasms, Genital Diseases, Male, Prostatic Diseases, Antineoplastic Agents, Imatinib
Keywords
Prostate cancer,, radical prostatectomy,, PSA rise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
imatinib mesylate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
STI571 (Glivec®)
Other Intervention Name(s)
Glivec
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
investigate the time to sustained biochemical response under the treatment of Glivec® in this patient population
Time Frame
continuous
Title
investigate duration of biochemical sustained response under the treatment with Glivec® in this patient population.
Time Frame
continuous
Title
To assess the response rates: number of patients with complete, partial and minor biochemical response and stable PSA
Time Frame
continuous
Title
To assess the time to clinical progression of this patient population treated with Glivec® at this dose and schedule.
Time Frame
continuous
Title
To descriptively characterize the safety and tolerability of Glivec® administered at this dose and schedule to this patient population.
Time Frame
continuous
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Aachen
Country
Germany
Facility Name
Novarts Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
Country
Germany
Facility Name
Novartis Investigative Site
City
Borken
Country
Germany
Facility Name
Novartis Investigative Site
City
Darmstadt
Country
Germany
Facility Name
Novartis Investigative Site
City
Fürth
Country
Germany
Facility Name
Novartis Investigative Site
City
Gardelegen
Country
Germany
Facility Name
Novarts Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Köln
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
Country
Germany
Facility Name
Novartis Investigative Site
City
Wesel
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuppertal
Country
Germany
12. IPD Sharing Statement
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Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy
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