Active — Not RecruitingPhase 4

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

United States155 participantsStarted 2013-03-26

Plain-language summary

The purpose of this study is to allow continued use of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and are benefiting from the treatment as judged by the investigator.

Who can participate

Age range0 Years – 100 Years

SexALL

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Inclusion criteria

✓. Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs study receiving imatinib and has fulfilled all their requirements in the parent study. 2.Patient is currently benefiting from the treatment with imatinib, as determined by the investigator. 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 5. Written informed consent obtained prior to enrolling in roll-over study. 6.If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion criteria

✕. 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. Male patients must use highly effective contraception during the study and for 30 days after the final dose of imatinib.

What they're measuring

To evaluate long term safety data (SAEs and AEs)

Timeframe: Until no patients are left on study, with an expected average of 20 years

Trial details

NCT IDNCT01742299

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-24

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