Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01316458

Collaborator

(none)

Enrollment

Locations

Arm

3.9

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasm Genital Neoplasms, Male Neoplasms, Abdominal Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Antineoplastic Agents Imatinib	Drug: STI571 (Glivec®)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: imatinib mesylate	Drug: STI571 (Glivec®) Other Names: Glivec

Arm

Intervention/Treatment

Experimental: imatinib mesylate

Drug: STI571 (Glivec®)

Other Names:

Glivec

Outcome Measures

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. [2 - 4 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Aachen	Germany
2	Novarts Investigative Site	Berlin	Germany
3	Novartis Investigative Site	Bonn	Germany
4	Novartis Investigative Site	Borken	Germany
5	Novartis Investigative Site	Darmstadt	Germany
6	Novartis Investigative Site	Fürth	Germany
7	Novartis Investigative Site	Gardelegen	Germany
8	Novarts Investigative Site	Hamburg	Germany
9	Novartis Investigative Site	Köln	Germany
10	Novartis Investigative Site	Marburg	Germany
11	Novartis Investigative Site	Ulm	Germany
12	Novartis Investigative Site	Wesel	Germany
13	Novartis Investigative Site	Wuppertal	Germany