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Cancer drug Imatinib's Long-Term safety tracked in ongoing patients

NCT ID NCT01742299

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 19, 2026 · Updated 4 times

Summary

This study looks at the long-term safety of imatinib, a daily pill for certain cancers like GIST and CML. It includes 250 patients who were already benefiting from imatinib in a previous Novartis trial and continue taking it. The main goal is to track side effects over time, with no new treatment being tested.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
imatinib (a targeted cancer drug taken as a daily pill)
What this could lead to
If successful, this study will confirm that long-term imatinib use is safe and continues to control GIST or CML, supporting its ongoing use.
What could go wrong
This is a roll-over safety study, not a test of new effectiveness. It only includes patients already benefiting, so results may not apply to all. Side effects remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

155 people

The number who actually took part.

Started

Mar 2013

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive gastrointestinal stromal tumor Leukemia, Myelogenous, Chronic, BCR-ABL Positive

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gist and CML

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210002, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Guangzhou, 510060, China

  • Novartis Investigative Site

    Shanghai, 200433, China

  • Novartis Investigative Site

    Helsinki, 00029, Finland

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Pessac, 33604, France

  • Novartis Investigative Site

    Poitiers, 86021, France

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400015, Romania

  • Novartis Investigative Site

    Bucharest, 022328, Romania

  • Novartis Investigative Site

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Sidney Kimmel CCC At JH

    Baltimore, Maryland, 21231, United States

  • Uni Of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030, United States

  • University of California LA

    Los Angeles, California, 90095, United States

  • Weill Cornell Medical Center

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.