GIST and CML Clinical Trial
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
| Verified date | May 2024 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 155 |
| Est. completion date | April 21, 2033 |
| Est. primary completion date | April 21, 2033 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: 1. 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: - 1. 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. 2. 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. 3. 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. 4. 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. Highly effective contraception is defined as either: - Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. 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 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Guangzhou | |
| China | Novartis Investigative Site | Nanjing | Jiangsu |
| China | Novartis Investigative Site | Shanghai | |
| Finland | Novartis Investigative Site | Helsinki | |
| France | Novartis Investigative Site | Lille | |
| France | Novartis Investigative Site | Pessac Cedex | |
| France | Novartis Investigative Site | Poitiers | |
| Hong Kong | Novartis Investigative Site | Hong Kong SAR | |
| Romania | Novartis Investigative Site | Bucharest | |
| Romania | Novartis Investigative Site | Cluj-Napoca | |
| Singapore | Novartis Investigative Site | Singapore | |
| Singapore | Novartis Investigative Site | Singapore | |
| Singapore | Novartis Investigative Site | Singapore | |
| Switzerland | Novartis Investigative Site | Basel | |
| Thailand | Novartis Investigative Site | Bangkok | |
| Turkey | Novartis Investigative Site | Ankara | |
| United Kingdom | Novartis Investigative Site | Sutton | Surrey |
| United Kingdom | Novartis Investigative Site | Withington | Greater Manchester |
| United States | Sidney Kimmel CCC At JH Dept of Onc | Baltimore | Maryland |
| United States | Dana Farber Cancer Institute SC 2 | Boston | Massachusetts |
| United States | Northwestern University Clinical Research Office | Chicago | Illinois |
| United States | Karmanos Cancer Institute Oncology Department | Detroit | Michigan |
| United States | Uni of TX MD Anderson Cancer Cntr UT MD Anderson | Houston | Texas |
| United States | University Of California LA UCLA | Los Angeles | California |
| United States | Weill Cornell Medical Center Dept of Oncology | New York | New York |
| United States | Fox Chase Cancer Center Dept.ofFoxChaseCancerCtr. | Philadelphia | Pennsylvania |
| United States | Oregon Health Sciences University Dept of Oncology | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, China, Finland, France, Hong Kong, Romania, Singapore, Switzerland, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate long term safety data (SAEs and AEs) | To better characterize the long-term safety of imatinib in patients who are on imatinib treatment and are benefiting from the treatment as judged by the investigator | Until no patients are left on study, with an expected average of 20 years | |
| Secondary | To evaluate clinical benefit as assessed by the investigator. | To better characterize the long-term safety of imatinib in patients who are on imatinib treatment and are benefiting from the treatment as judged by the investigator | Until no patients are left on study, with an expected average of 20 years |