An open-label multicenter phase II study of Imatinib mesylate (Glivec) treatment of patients with malignant peripheral nerve sheath tumors

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2005-004774-24-DE
• Date of registration: 17/01/2006
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma GmbH
• Public title: An open-label multicenter phase II study of Imatinib mesylate (Glivec) treatment of patients with malignant peripheral nerve sheath tumors
• Scientific title: An open-label multicenter phase II study of Imatinib mesylate (Glivec) treatment of patients with malignant peripheral nerve sheath tumors
• Date of first enrolment: 09/03/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004774-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients >=18 years of age.
2. Histologically documented diagnosis of malignant MPNST
3. Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach
4. Karnofsky Index must be at least 70 %
5. Adequate end organ function defined as the following:
Total bilirubin < 1.5 UNL, GPT and GOT < 2.5 UNL (or < 5 UNL if liver
metastases are present) creatinine <1.5 UNL, ANC > 1.5 x 109/l, platelets > 100x109/l,
6. Written, informed consent.
7. Life expectancy of at least 6 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patient has received any other investigational agents within 28 days of first day of study drug dosing.
2. Chemotherapy and or radiotherapy in between the last 6 weeks before study entry.
3. Patient has received radiotherapy to 25 % of the bone marrow.
4. Surgery in between the last 14 days before study entry.
5. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
6. Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
7. Female patients who are pregnant or breast feeding.
8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using a highly effective method of birth control. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% a year) when used consistently and correctly. The following methods are fulfilling the criteria of a highly effective method of birth control:
· Surgical sterilization (e.g., bilateral tubal ligation, vasectomy)
· Implants
· Injectables
· Combined oral contraception
· Some IUDs
Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 4 weeks after study drug discontinuation.
Women of childbearing potential must have a negative serum pregnancy test = 48 hours prior to the administration of study medication.
9. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
10. The concurrent use of warfarin or acetaminophen are not allowed with imatinib and need to be replaced by other medications (e.g. by low molecular heparins in case of warfarin).
11. Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
12. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
13. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
14. Known CNS metastases


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

malignant nerve sheath tumor

Intervention(s)

Product Name: Glivec Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Imatinib
CAS Number: 220127-57-1
Current Sponsor code: STI571
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Glivec Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Imatinib
CAS Number: 220127-57-1
Current Sponsor code: STI571
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Primary Outcome(s)

Secondary Objective: • To assess time to progression (TTP).
• To assess overall survival
• To assess of safety and tolerability.

Main Objective: To assess response in patients with MPNST treated with Imatinib. Response is defined as at least stable disease according to RECIST criteria.

Primary end point(s): Primary objective of the study is to evaluate the response in patients with MPNST treated with Imatinib.

Secondary ID(s)

CSTI571BDE57