Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

Prostatic Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316458
• Other study ID #: CSTI571BDE15
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2011
• Last updated: May 31, 2017
• Start date: June 2003

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Antineoplastic Agents
• Genital Diseases, Male
• Genital Neoplasms, Male
• Imatinib
• Neoplasms
• Neoplasms, Abdominal
• Prostatic Diseases
• Prostatic Neoplasm
• Prostatic Neoplasms
• Urogenital Neoplasms

Intervention

Drug:
• STI571 (Glivec®)

Locations

Country	Name	City	State
Germany	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	Fürth
Germany	Novartis Investigative Site	Gardelegen
Germany	Novarts Investigative Site	Hamburg
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wesel
Germany	Novartis Investigative Site	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	investigate the time to sustained biochemical response under the treatment of Glivec® in this patient population		continuous
Secondary	investigate duration of biochemical sustained response under the treatment with Glivec® in this patient population.		continuous
Secondary	To assess the response rates: number of patients with complete, partial and minor biochemical response and stable PSA		continuous
Secondary	To assess the time to clinical progression of this patient population treated with Glivec® at this dose and schedule.		continuous
Secondary	To descriptively characterize the safety and tolerability of Glivec® administered at this dose and schedule to this patient population.		continuous

External Links

•   Embase 70062155
•   Results for CSTI571BDE15 on the Novartis Clinical Trial Results Website