Imatinib Access for Cancer

Not currently recruiting at 58 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Novartis Pharmaceuticals

Must be taking: Imatinib

Disqualifiers: Pregnancy, Nursing, Combination therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial allows patients to continue using imatinib if they have already benefited from it in a previous Novartis study. Imatinib treats certain types of cancer, and the trial ensures that patients experiencing positive effects can keep taking it. It suits those currently on imatinib in a related study, showing improvement, and adhering to the treatment plan. As a Phase 4 trial, this study involves an FDA-approved treatment and focuses on understanding how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it is clear that you must continue taking imatinib if you are benefiting from it.

What is the safety track record for imatinib?

Research has shown that patients generally tolerate imatinib well. One study found that its side effects were similar to those in people with chronic myeloid leukemia, indicating they are manageable. Another study discovered that lower doses of imatinib resulted in fewer side effects, making it easier for patients to handle while maintaining effectiveness. The FDA has already approved this treatment for several conditions, supporting its safety. Overall, evidence suggests that imatinib is safe to use, with side effects that are common but usually mild. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Imatinib is unique because it specifically targets cancer cells by inhibiting the BCR-ABL tyrosine kinase, which is the abnormal protein driving certain types of cancer like chronic myeloid leukemia (CML). Unlike standard chemotherapy, which attacks both healthy and cancerous cells, imatinib zeroes in on the cancer-causing protein, potentially leading to fewer side effects. Researchers are excited about imatinib because it has transformed CML from a potentially deadly disease into a manageable chronic condition, and it continues to show promise in improving patient outcomes.

What is the effectiveness track record for imatinib in cancer treatment?

Research has shown that imatinib, the treatment under study in this trial, is effective for certain cancers. In one study, about 84% of patients experienced a halt in tumor growth, and 16% saw their tumors shrink. Another study found that more than half of patients with advanced tumors responded well to the treatment over time. Imatinib is approved for use against seven different diseases, including two types of solid tumors and five blood disorders. It has a strong track record, with some patients having an estimated 83.3% survival rate at 10 years. Overall, imatinib has proven valuable in fighting cancer. ^{2 3 5 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements

I am responding well to my current imatinib treatment.

I am willing and able to follow the study's schedule and procedures.

Exclusion Criteria

Use of ineffective contraception methods

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue imatinib treatment as per the last dose in the parent study, with dose adjustments based on the investigator's judgment

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

Follow-up

Participants are monitored for long-term safety and clinical benefit

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

What Are the Treatments Tested in This Trial?

Interventions

• Imatinib

Trial Overview 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.

How Is the Trial Designed?

Group I: imatinib mesylate Experimental Treatment 1 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.

Imatinib is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Gleevec for:

• Chronic myeloid leukemia
• Gastrointestinal stromal tumors
• Dermatofibrosarcoma protuberans
• Systemic mastocytosis
• Hypereosinophilic syndrome

Approved in United States as Gleevec for:

• Chronic myeloid leukemia
• Gastrointestinal stromal tumors
• Dermatofibrosarcoma protuberans
• Systemic mastocytosis
• Hypereosinophilic syndrome

Approved in Canada as Glivec for:

• Chronic myeloid leukemia
• Gastrointestinal stromal tumors
• Dermatofibrosarcoma protuberans
• Systemic mastocytosis
• Hypereosinophilic syndrome

Approved in Japan as Glivec for:

• Chronic myeloid leukemia
• Gastrointestinal stromal tumors
• Dermatofibrosarcoma protuberans
• Systemic mastocytosis
• Hypereosinophilic syndrome

Approved in Switzerland as Gleevec for:

• Chronic myeloid leukemia
• Gastrointestinal stromal tumors
• Dermatofibrosarcoma protuberans
• Systemic mastocytosis
• Hypereosinophilic syndrome

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

Imatinib mesylate (Glivec) significantly improves post-recurrence and overall survival rates in patients with advanced small bowel gastrointestinal stromal tumors (GISTs), with a 67.8% partial response rate observed in treated patients.

The majority of GIST patients showed activated mutations in the c-kit gene, particularly exon 11, but there was no significant difference in response rates between patients with exon 9 and exon 11 mutations, indicating Glivec's efficacy across different mutation types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of patients with advanced gastrointestinal stromal tumor of small bowel: implications of imatinib mesylate. Yeh, CN., Chen, TW., Wu, TJ., et al.[2019]

Imatinib mesylate (Glivec) is the standard first-line treatment for chronic myeloid leukemia (CML) due to its high response rates and favorable safety profile, but switching to a copy version of the drug may lead to treatment failure, as seen in two case studies.

In one case, a patient relapsed after switching to the copy drug, while another patient experienced severe complications and died shortly after the switch, highlighting the need for caution and further research on the safety and efficacy of copy versions of imatinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing therapy from Glivecto a "copy" imatinib results in a worsening of chronic myeloid leukemia disease status: two case reports. Asfour, IA., Elshazly, SA.[2023]

Imatinib mesylate, a tyrosine kinase inhibitor used for treating chronic myeloid leukemia and gastrointestinal stromal tumors, is generally well-tolerated, with most patients experiencing only mild side effects (grade 1 or 2).

Approximately 30% of patients on imatinib develop skin toxicity, with 5% experiencing high-grade reactions, including cases of extensive skin hyperpigmentation, which is linked to the drug's effect on melanocytes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpigmentation due to imatinib: A rare case of cutaneous involvement. Rehman, H., Hakim, N., Sugarman, R., et al.[2020]

Imatinib mesylate (Gleevec) is a highly effective oral anticancer drug that specifically targets protein tyrosine kinases involved in chronic myeloid leukemia and gastrointestinal stromal tumors, showing remarkable clinical efficacy.

The treatment is generally well tolerated with a low risk of severe side effects, and most adverse effects, such as mild edema and nausea, are manageable without needing to stop therapy permanently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for imatinib mesylate therapy and clinical management. Guilhot, F.[2019]

Imatinib (Gleevec) has shown high efficacy in treating chronic myelogenous leukemia (CML) and gastrointestinal stromal tumors (GIST), with over 12,000 patients involved in clinical trials, indicating its effectiveness as a treatment option.

The drug is generally well tolerated, with manageable common side effects such as nausea and rash, and ongoing studies have helped identify rarer toxicities and predictors of common side effects, as well as its impact on male fertility and pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imatinib treatment: specific issues related to safety, fertility, and pregnancy. Hensley, ML., Ford, JM.[2022]

Imatinib (Gleevec) has been shown to be highly effective in treating all stages of chronic myelogenous leukemia (CML), with over 12,000 patients treated during its clinical development.

In a randomized study, first-line imatinib therapy demonstrated superior efficacy and safety compared to traditional treatments involving interferon and cytarabine, highlighting its role as a targeted anticancer agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imatinib: a targeted clinical drug development. Capdeville, R., Silberman, S.[2021]

Imatinib mesylate, a drug used to treat chronic myeloid leukemia, may be linked to ischemic maculopathy, which can lead to significant vision problems, as demonstrated in a case study of a 62-year-old woman.

The patient developed severe visual impairment and retinal abnormalities after starting imatinib therapy, highlighting the need for careful monitoring of patients for visual symptoms while on this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular ischemia associated with imatinib mesylate therapy for chronic myeloid leukemia. Roth, DB., Akbari, S., Rothstein, A.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5901965/

Long-Term Outcomes of Imatinib Treatment for Chronic ... Among the patients in the imatinib group, the estimated overall survival rate at 10 years was 83.3%. Approximately half the patients (48.3%) who had been ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4055302/

Imatinib: A Breakthrough of Targeted Therapy in Cancer - PMC Treatment with Imatinib was successful in stabilizing tumor growth (84%) or shrinking tumor size (16%) in a cohort of patients with progressing, advanced ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa020461

Efficacy and Safety of Imatinib Mesylate in Advanced ... Imatinib induced a sustained objective response in more than half of patients with an advanced unresectable or metastatic gastrointestinal stromal tumor.

4. mpnresearchfoundation.org mpnresearchfoundation.org/news/gleevecr-approved-in-the-us-for-five-rare-life-threatening-disorders-with-limited-treatment-options/

GLEEVEC(R) APPROVED IN THE US FOR FIVE RARE ... Gleevec has now been approved in the US for seven diseases, including two solid tumors and five blood disorders with molecular targets known to be inhibited by ...

5. news.ohsu.edu news.ohsu.edu/2017/03/08/new-england-journal-of-medicine-publishes-long-term-results-of-gleevecR-for-patients-with-chronic-myeloid-leukemia

New England Journal of Medicine publishes long-term ... A recent study published in JAMA Oncology found that nearly 1 in 4 GIST patients treated with Gleevec will survive 10 years.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9475133/

Real‐world efficacy and safety outcomes of imatinib treatment ... Survival outcomes with imatinib‐treatment in this study (3‐year OS of 95%, PFS of 93%, and EFS of 81%) are consistent with results of other real‐world and ...

7. hksmp.com hksmp.com/journals/git/article/view/482

Safety outcomes of low versus high dose imatinib mesylate ... Low dose imatinib provides clinically meaningful response and demonstrated better tolerability with less frequently reported reactions.