GIST and CMLPhase 4NCT01742299
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
A Phase 4 study testing imatinib mesylate in people with GIST and CML, run by Novartis Pharmaceuticals at 29 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- GIST and CML
- What is being tested?
- imatinib mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 29 sitesin 11 countries
- Study dates
- 26 Mar 2013to 20 Apr 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
29 sites in 11 countries.
29 sites in 11 countries
United States9 sites
Sidney Kimmel CCC At JH
Baltimore, Maryland, 21231
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
Karmanos Cancer Institute
Detroit, Michigan, 48201
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
University of California LA
Los Angeles, California, 90095
Weill Cornell Medical Center
New York, New York, 10021
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health Sciences University
Portland, Oregon, 97239
China5 sites
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Guangzhou, 510060
Novartis Investigative Site
Nanjing, Jiangsu, 210002
Novartis Investigative Site
Shanghai, 200433
France3 sites
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Poitiers, 86021
Singapore3 sites
Novartis Investigative Site
Singapore, 119228
Novartis Investigative Site
Singapore, 168583
Novartis Investigative Site
Singapore, 169608
Romania2 sites
Novartis Investigative Site
Bucharest, 022328
Novartis Investigative Site
Cluj-Napoca, Cluj, 400015
United Kingdom2 sites
Novartis Investigative Site
Manchester, M20 2BX
Novartis Investigative Site
Sutton, Surrey, SM2 5PT
Turkey (Türkiye)1 site
Novartis Investigative Site
Ankara, Sihhiye-Altindag, 06230
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- GIST and CML
- Being tested
- imatinib mesylate
- Keywords
- Glivec/Gleevec, Chronic Myeloid Leukemia (CML), Gastrointestinal Stromal Tumors (GIST), Imatinib mesylate
- Medical subject headings
- Gastrointestinal Stromal Tumors, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Also called STI571
Imatinib will be provided as 100 mg and 400 mg tablets taken orally once daily unless other wise instructed by investigator
| Study group | Role | What they receive |
|---|---|---|
| imatinib mesylate | Experimental | 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. Receives: Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluation of long-term safety based on the frequency and severity of adverse events and serious adverse events occurring during the study.
Measured: From first dose of study treatment until 30 days after the last dose of study treatment, assessed up to approximately 13 years
Frequency and severity of Adverse Events (AEs) / Serious Adverse Events (SAEs)
To evaluate long term safety data (SAEs and AEs)
Measured: Until no patients are left on study, with an expected average of 20 years
Secondary outcomes (2)
Proportion of Participants With Clinical Benefit as Assessed by the Investigator
Assessment of continued clinical benefit based on investigator evaluation during scheduled study visits.
Measured: Up to approximately 13 years
Proportion of patients with clinical benefit as assessed by the investigator
To evaluate clinical benefit as assessed by the investigator
Measured: Until no patients are left on study, with an expected average of 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study start26 Mar 2013
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GIST and CMLStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742299
- Sponsor's protocol ID
- CSTI571A2406
- Other IDs
- 2012-002540-25
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2012
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com