Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01316458
First received: March 14, 2011
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Prostatic Neoplasms,
Genital Neoplasms, Male,
Neoplasms,
Urogenital Neoplasms,
Genital Diseases, Male,
Prostatic Diseases,
Antineoplastic Agents,
Imatinib
Drug: STI571 (Glivec®)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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. [ Time Frame: 2 - 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • investigate the time to sustained biochemical response under the treatment of Glivec® in this patient population [ Time Frame: continuous ] [ Designated as safety issue: No ]
  • investigate duration of biochemical sustained response under the treatment with Glivec® in this patient population. [ Time Frame: continuous ] [ Designated as safety issue: No ]
  • To assess the response rates: number of patients with complete, partial and minor biochemical response and stable PSA [ Time Frame: continuous ] [ Designated as safety issue: No ]
  • To assess the time to clinical progression of this patient population treated with Glivec® at this dose and schedule. [ Time Frame: continuous ] [ Designated as safety issue: No ]
  • To descriptively characterize the safety and tolerability of Glivec® administered at this dose and schedule to this patient population. [ Time Frame: continuous ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: June 2003
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: imatinib mesylate Drug: STI571 (Glivec®)
Other Name: Glivec

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316458

Locations
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, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01316458     History of Changes
Other Study ID Numbers: CSTI571BDE15
Study First Received: March 14, 2011
Last Updated: March 15, 2011
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by Novartis:
Prostate cancer,
radical prostatectomy,
PSA rise

Additional relevant MeSH terms:
Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Prostatic Diseases
Prostatic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014