Study to allow access to imatinib for patients who are on imatinib treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2012-002540-25-GB
• Date of registration: 12/03/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study to allow access to imatinib for patients who are on imatinib treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.
• Scientific title: An open label, multi-center imatinib roll-over protocol for patients who have completed a previous Novartis sponsored imatinib study and are judged by the investigator to benefit from continued imatinib treatment
• Date of first enrolment: 22/04/2013
• Target sample size: 200
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002540-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: roll-over protocol; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

China, Finland, France, Hong Kong, Romania, Singapore, Switzerland, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Medical Collaboration Centre
• Affiliation: Novartis Pharmaceuticals UK Ltd

• Name: Medical Collaboration Centre
• Affiliation: Novartis Pharmaceuticals UK Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Patient is currently enrolled in a Novartis- sponsored, Oncology Global Development & Global Medical Affairs study receiving imatinib and has
fulfilled all their requirements in the parent study.
Patient is currently benefiting from the treatment with imatinib, as determined by the investigator.
Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patient has been permanently discontinued from imatinib study treatment in the
parent study due to unacceptable toxicity, non-compliance to study procedures,
withdrawal of consent or any other reason.
Patient has participated in a Novartis sponsored combination trial where imatinib
was dispensed in combination with another study medication and is still receiving
combination therapy.


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

Health Condition(s) or Problem(s) studied

Male and female patients who are currently enrolled in a Novartissponsored, Oncology OGD&GMA imatinib study, are benefiting from treatment with imatinib and have fulfilled all their requirements in the parent study.

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Glivec
Product Name: Glivec
Product Code: STI571
Pharmaceutical Form: Tablet
INN or Proposed INN: imatinib
CAS Number: 152459-95-5
Current Sponsor code: STI571
Other descriptive name: IMATINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100 and 400-

Trade Name: Glivec
Product Name: Glivec
Product Code: STI571
Pharmaceutical Form: Tablet
INN or Proposed INN: imatinib
CAS Number: 152459-95-5
Current Sponsor code: STI571
Other descriptive name: IMATINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100 and 400-

Primary Outcome(s)

Main Objective: To evaluate long term safety data (SAEs and AEs).

Primary end point(s): Frequency and severity of AEs/SAEs.

Secondary Objective: To evaluate clinical benefit as assessed by the investigator.

Secondary Outcome(s)

Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.

Secondary ID(s)

CSTI571A2406

2012-002540-25-FI

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 22/04/2013
Contact: