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

Novartis

Status and phase: Completed; Phase 4

Conditions: GIST and CML

Treatments: Drug: imatinib mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01742299

2012-002540-25 (EudraCT Number)

CSTI571A2406

Details and patient eligibility

About

The purpose of this study is to better characterize the long-term safety of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Global Development & Global Medical Affairs (OGD&GMA) study and are benefiting from the treatment as judged by the investigator.

Full description

The study will not include a screening phase as patients will transfer directly from parent studies and will commence treatment with imatinib as soon as they are consented and meet the inclusion criteria of the roll-over protocol.

Patients will continue to be treated until they are no longer benefiting from imatinib treatment, develop unacceptable toxicities, withdraw consent, are non-compliant to the protocol, the investigator feels it is no longer in the patient's best interest to continue imatinib therapy or the patient dies, whichever comes first. Patients are allowed to switch to the commercial supply in accordance with the regulation of the respective country.

A patient will reach the end of study when imatinib treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 30 days after the last dose of study treatment. Following this there are no further follow-up study visits.

Enrollment: 155 patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is currently enrolled in a Novartis-sponsored, Global Drug 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.
• Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
• Written informed consent obtained prior to enrolling in roll-over study.
• If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion criteria

• Patient has been permanently discontinued from imatinib 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 patient is still receiving combination therapy.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of imatinib.

Highly effective contraception is defined as either:

• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or total hysterectomy, bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
• Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.

In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.

If a study patient becomes pregnant or suspects they are pregnant during the study or within 30 days of the final dose of imatinib, the Investigator/Study Doctor needs to be informed immediately and ongoing study treatment with imatinib has to be stopped immediately.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

imatinib mesylate

Experimental group

Description:

The starting dose of imatinib should be the same as the last dose that was given in the parent imatinib study (400 mg/day to 600 mg/day). After this, the dose of imatinib is based on the investigator's judgment.

Treatment:

Drug: imatinib mesylate