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Tyrosine Kinase Inhibitor
Imatinib Access for Cancer
Phase 4
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until no patients are left on study, with an expected average of 20 years
Awards & highlights
Study Summary
This trial allows Novartis to keep giving imatinib to patients who are doing well on it, as decided by their doctor.
Who is the study for?
This trial is for patients already benefiting from Imatinib in a Novartis study for Gastrointestinal Stromal Tumor or Chronic Myeloid Leukemia. They must have complied with the previous study's protocol, be willing to follow this trial's procedures, and provide consent. Pregnant women, those who can become pregnant without effective contraception, and men not using contraception are excluded.Check my eligibility
What is being tested?
The trial allows continued access to Imatinib mesylate for patients previously enrolled in a Novartis-sponsored study. It aims to assess ongoing benefits of Imatinib treatment as determined by the investigator overseeing individual cases.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones associated with Imatinib may include nausea, muscle cramps, fatigue, diarrhea, rash and edema. Patients' experiences may vary based on their condition and other factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently in a Novartis cancer study and have met all its requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until no patients are left on study, with an expected average of 20 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until no patients are left on study, with an expected average of 20 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate long term safety data (SAEs and AEs)
Secondary outcome measures
To evaluate clinical benefit as assessed by the investigator.
Side effects data
From 2013 Phase 1 & 2 trial • 14 Patients • NCT0128186575%
Anemia
75%
Hyperglycemia
75%
Platelet count decreased
67%
Hypertriglyceridemia
67%
White blood cell decreased
67%
Hypophosphatemia
58%
Aspartate aminotransferase increased
58%
Cholesterol high
42%
Fatigue
42%
Hypokalemia
42%
Alanine aminotransferase increased
33%
Hypoalbuminemia
33%
Lymphocyte count decreased
33%
Mucositis-oral
33%
Alkaline phosphatase increased
25%
Diarrhea
25%
Creatinine increased
25%
Neutrophil count decreased
25%
Rash maculo-papular
17%
Hypernatremia
17%
Blood bilirubin increased
17%
Hypocalcemia
17%
Nausea
8%
Intra-abdominal hemorrhage
8%
Constipation
8%
Dyspnea
8%
Papulopustular rash
8%
Peripheral sensory neuropathy
8%
Pneumonitis
8%
Tumor pain
8%
Anorexia
8%
Cough
8%
Hyponatremia
8%
Skin and subcutaneous tissue disorders Other, specify-dry split fingernails
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Trial Design
1Treatment groups
Experimental Treatment
Group I: imatinib mesylateExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
imatinib mesylate
1993
Completed Phase 3
~3670
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,195 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped taking imatinib in a previous study due to side effects or other reasons.I am currently in a Novartis trial taking imatinib with another study drug.I am a woman able to have children and am not using strong birth control methods.I am not pregnant and will not become pregnant during the study or within 30 days after the last dose of imatinib.I am responding well to my current imatinib treatment.I am willing and able to follow the study's schedule and procedures.I am a male not using strong birth control methods.I am currently in a Novartis cancer study and have met all its requirements.
Research Study Groups:
This trial has the following groups:- Group 1: imatinib mesylate
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions is imatinib mesylate generally employed for?
"Imatinib mesylate is a widely used treatment for newly diagnosed acute lymphoblastic leukaemia and other maladies such as refractory all, muscular dystrophy, and metastatic dermatofibrosarcoma protuberans."
Answered by AI
How many venues are currently hosting this research project?
"10 sites are enrolling participants for this clinical trial. Examples of these locations include Fox Chase Cancer Center Dept.ofFoxChaseCancerCtr., Lurie Children's Hospital of Chicago Clinical Research Office, and University of California at Los Angeles UCLA; there are also 7 other medical centres participating in the study."
Answered by AI
Are there vacancies in this research program for volunteers?
"Clinicaltrials.gov indicates that this clinical trial, initially shared on March 26th 2013 and last updated April 25th 2022, is not recruiting patients currently. Nevertheless, 54 other trials are enrolling participants at the moment."
Answered by AI
Has the FDA given its stamp of approval to imatinib mesylate?
"A score of 3 has been assigned to imatinib mesylate due its Phase 4 status, which implies that it is an approved medication for therapeutic use."
Answered by AI
To what extent is the trial population being prescribed this treatment?
"Unfortunately, this clinical trial is not open to new enrolment at this time. Initially posted on March 26th 2013 and last modified April 25th 2022, it no longer seeks candidates. If you are interested in other studies, presently there are two ongoing trials recruiting participants with GIST or CML and fifty-two investigations involving Imatinib Mesylate that require volunteers."
Answered by AI
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