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: 4 September 2023
• Main ID: EUCTR2012-002540-25-FI
• Date of registration: 14/01/2013
• 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: 19/02/2013
• Target sample size: 200
• Recruitment status: Not Recruiting
• 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: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

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 Novartis-sponsored, 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: 400-
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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Safety will be monitored by collecting of the adverse events at every quarterly visit (every 12 weeks)

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.

Timepoint(s) of evaluation of this end point: At every quarterly visit (every 12 weeks), the investigator is required to confirm that the patient continues to have clinical benefit and may continue receiving study treatment

Secondary ID(s)

CSTI571A2406

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 23/01/2013
Contact: