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Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Neoplasms,; Genital Neoplasms, Male,; Neoplasms,; Urogenital Neoplasms,; Genital Diseases, Male,; Prostatic Diseases,; Antineoplastic Agents,; Imatinib

Intervention: STI571 (Glivec®) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Secondary outcome:

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Novartis Investigative Site, Aachen, Germany

Novarts Investigative Site, Berlin, Germany

Novartis Investigative Site, Bonn, Germany

Novartis Investigative Site, Borken, Germany

Novartis Investigative Site, Darmstadt, Germany

Novartis Investigative Site, F├╝rth, Germany

Novartis Investigative Site, Gardelegen, Germany

Novarts Investigative Site, Hamburg, Germany

Novartis Investigative Site, K├Âln, Germany

Novartis Investigative Site, Marburg, Germany

Novartis Investigative Site, Ulm, Germany

Novartis Investigative Site, Wesel, Germany

Novartis Investigative Site, Wuppertal, Germany

Additional Information

Starting date: June 2003
Last updated: November 13, 2014

Page last updated: August 23, 2015

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