Imatinib Access for Cancer

Recruiting at 57 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

155 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Imatinib?

Imatinib has been shown to be highly effective in treating chronic myeloid leukemia (CML) and metastatic gastrointestinal stromal tumors (GIST), with high response rates and durable remissions. It works by specifically targeting certain proteins that contribute to cancer growth, and it is generally well tolerated with few severe side effects. ^{1 2 3 4 5}

Is imatinib generally safe for humans?

Imatinib, also known as Gleevec or Glivec, is generally well tolerated in humans, with most side effects being mild to moderate, such as swelling, nausea, diarrhea, and skin rashes. Serious side effects are rare, and the treatment is usually manageable without needing to stop the medication. ^{6 7 8 9 10}

How is the drug Imatinib unique compared to other treatments for cancer?

Imatinib is unique because it is a targeted therapy that specifically inhibits certain proteins (tyrosine kinases) involved in cancer cell growth, making it highly effective for chronic myeloid leukemia and gastrointestinal stromal tumors. It is taken orally and has shown superior efficacy and safety compared to older treatments like interferon and cytarabine. ^{1 4 8 11 12}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 (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 (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 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 (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 (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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Imatinib: a targeted clinical drug development. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Imatinib mesylate. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

A comprehensive review of imatinib mesylate (Gleevec) for dermatological diseases. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Failure of a non-authorized copy product to maintain response achieved with imatinib in a patient with chronic phase chronic myeloid leukemia: a case report. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of patients with advanced gastrointestinal stromal tumor of small bowel: implications of imatinib mesylate. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Hyperpigmentation due to imatinib: A rare case of cutaneous involvement. [2020]

8. England 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. [2023]

9. Spain pubmed.ncbi.nlm.nih.gov

Adverse skin effects of imatinib, a tyrosine kinase inhibitor. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Macular ischemia associated with imatinib mesylate therapy for chronic myeloid leukemia. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Plasma and cerebrospinal fluid pharmacokinetics of imatinib after administration to nonhuman primates. [2019]