Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy
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
1 other identifier
interventional
51
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedJune 1, 2017
March 1, 2011
7.1 years
March 14, 2011
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 - 4 weeks
Secondary Outcomes (5)
investigate the time to sustained biochemical response under the treatment of Glivec® in this patient population
continuous
investigate duration of biochemical sustained response under the treatment with Glivec® in this patient population.
continuous
To assess the response rates: number of patients with complete, partial and minor biochemical response and stable PSA
continuous
To assess the time to clinical progression of this patient population treated with Glivec® at this dose and schedule.
continuous
To descriptively characterize the safety and tolerability of Glivec® administered at this dose and schedule to this patient population.
continuous
Study Arms (1)
imatinib mesylate
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Novartis Investigative Site
Aachen, Germany
Novarts Investigative Site
Berlin, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Borken, Germany
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Darmstadt, Germany
Novartis Investigative Site
Fürth, Germany
Novartis Investigative Site
Gardelegen, Germany
Novarts Investigative Site
Hamburg, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Wesel, Germany
Novartis Investigative Site
Wuppertal, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 16, 2011
Study Start
June 1, 2003
Primary Completion
July 1, 2010
Last Updated
June 1, 2017
Record last verified: 2011-03