28 Participants Needed

Imatinib for Gastrointestinal Stromal Cancer

YA
Overseen ByYvonne A Taul, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Reema A. Patel
Must be taking: Imatinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain drugs that affect liver enzymes (CYP3A or CYP3A4) or are on oral warfarin. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Imatinib for treating gastrointestinal stromal cancer?

Imatinib, a drug that targets specific cancer cell growth signals, has been shown to improve survival in patients with gastrointestinal stromal tumors (GISTs), especially when traditional chemotherapy is ineffective. Studies have reported good responses in cases of advanced GISTs, with many patients experiencing remission or disease stabilization.12345

Is imatinib safe for treating gastrointestinal stromal tumors?

Imatinib is generally considered safe for treating gastrointestinal stromal tumors, with most side effects being mild and occurring early in treatment. Serious side effects are rare, and the drug is well tolerated over long-term use.678910

What makes the drug imatinib unique for treating gastrointestinal stromal cancer?

Imatinib is unique because it specifically targets and inhibits the KIT protein, which is often mutated and overactive in gastrointestinal stromal tumors, leading to uncontrolled cell growth. This targeted approach is more effective than traditional chemotherapy, which generally has poor results for this type of cancer.511121314

What is the purpose of this trial?

Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.

Research Team

RP

Reema Patel, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

Adults over 18 with a specific type of tumor called GIST and certain genetic mutations can join. They should be starting or have recently started taking Imatinib, have good performance status, and normal organ function. Those with uncontrolled illnesses, on warfarin, other cancer treatments within 6 months without disease evidence, or allergies to Imatinib cannot participate.

Inclusion Criteria

My organs are functioning normally.
My GIST tumor has a KIT or PDGFRA mutation, but not D842V.
I am fully active or can carry out light work.
See 2 more

Exclusion Criteria

I have another type of cancer besides the one being treated.
I am not taking medication that strongly affects certain liver enzymes.
I am allergic to imatinib or similar drugs.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive imatinib with therapeutic drug monitoring to improve quality of life and symptoms

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Imatinib
Trial Overview The trial is testing if monitoring the levels of the drug Imatinib in the blood can improve life quality for patients with gastrointestinal stromal tumors (GIST) while maintaining its effectiveness. It involves checking free drug levels and how the body processes the drug.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Imatinib TDMExperimental Treatment1 Intervention
Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.

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

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Approved in European Union as Gleevec for:
  • Chronic myeloid leukemia
  • Gastrointestinal stromal tumors
  • Dermatofibrosarcoma protuberans
  • Systemic mastocytosis
  • Hypereosinophilic syndrome
πŸ‡ΊπŸ‡Έ
Approved in United States as Gleevec for:
  • Chronic myeloid leukemia
  • Gastrointestinal stromal tumors
  • Dermatofibrosarcoma protuberans
  • Systemic mastocytosis
  • Hypereosinophilic syndrome
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Approved in Canada as Glivec for:
  • Chronic myeloid leukemia
  • Gastrointestinal stromal tumors
  • Dermatofibrosarcoma protuberans
  • Systemic mastocytosis
  • Hypereosinophilic syndrome
πŸ‡―πŸ‡΅
Approved in Japan as Glivec for:
  • Chronic myeloid leukemia
  • Gastrointestinal stromal tumors
  • Dermatofibrosarcoma protuberans
  • Systemic mastocytosis
  • Hypereosinophilic syndrome
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Approved in Switzerland as Gleevec for:
  • Chronic myeloid leukemia
  • Gastrointestinal stromal tumors
  • Dermatofibrosarcoma protuberans
  • Systemic mastocytosis
  • Hypereosinophilic syndrome

Find a Clinic Near You

Who Is Running the Clinical Trial?

Reema A. Patel

Lead Sponsor

Trials
2
Recruited
210+

Findings from Research

In a study of 84 patients with imatinib-resistant gastrointestinal stromal tumors, surgical resection was found to significantly improve progression-free survival, with a hazard ratio of 0.50, indicating a 50% reduction in the risk of disease progression after surgery.
Although resection did not show a significant impact on overall survival (hazard ratio 0.62), the findings suggest that surgery may still be beneficial for selected patients, especially considering the median overall survival after developing resistance was 51 months.
Imatinib-resistant gastrointestinal stromal tumors in the era of second- and third-line tyrosine kinase inhibitors: Does surgical resection have a role?Sutton, TL., Walker, BS., Billingsley, KG., et al.[2021]
In a study of 62 patients with gastrointestinal stromal tumors (GIST) treated with imatinib mesylate for a median of 26 months, four distinct patterns of disease progression were identified, which have different implications for patient outcomes.
Patients with new cystic lesions (NCL) showed a significantly higher response to increased doses of imatinib and had better overall survival compared to those with new solid lesions (NSL) or general progression (GP), highlighting the importance of recognizing progression patterns for treatment decisions.
Patterns of progression in gastrointestinal stromal tumor treated with imatinib mesylate.Ryu, MH., Lee, JL., Chang, HM., et al.[2022]
In a study of 12 cases of gastric mesenchymal tumors, 67% were identified as GISTs, with gastrointestinal bleeding being the most common symptom and a significant number presenting with palpable abdominal masses.
Imatinib Mesylate showed a good response in a case of metastatic GIST, highlighting its potential as a palliative treatment option, especially when combined with surgical resection for advanced lesions.
Gastric GISTs. Personal experience.Mingolla, GP., Riccio, PA., Linguerri, R., et al.[2015]

References

Imatinib-resistant gastrointestinal stromal tumors in the era of second- and third-line tyrosine kinase inhibitors: Does surgical resection have a role? [2021]
Patterns of progression in gastrointestinal stromal tumor treated with imatinib mesylate. [2022]
Gastric GISTs. Personal experience. [2015]
[Imatinib mesylate STI571 therapy for five patients with advanced gastrointestinal stromal tumors]. [2015]
Imatinib and gastrointestinal stromal tumor (GIST): a selective targeted therapy. [2019]
The safety profile of imatinib in CML and GIST: long-term considerations. [2015]
Imatinib mesylate for the treatment of gastrointestinal stromal tumours: best monitored with FDG PET. [2022]
[The effect of imatinib for gastrointestinal tumor]. [2015]
A benefit-risk assessment of imatinib in chronic myeloid leukaemia and gastrointestinal stromal tumours. [2021]
Use of imatinib mesylate in gastrointestinal stromal tumours: Pan-Birmingham Cancer Network experience. [2015]
Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. [2022]
Outcomes of patients with metastatic gastrointestinal stromal tumors (GIST) treated with multi-kinase inhibitors other than imatinib as first-line treatment. [2022]
Role of imatinib mesylate (Gleevec/Glivec) in gastrointestinal stromal tumors. [2015]
Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study. [2022]
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