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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

Must not have

Male patients not using highly effective contraception

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until no patients are left on study, with an expected average of 20 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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 below

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I am currently in a Novartis cancer study and have met all its requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a male not using strong birth control methods.

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I stopped taking imatinib in a previous study due to side effects or other reasons.

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I am currently in a Novartis trial taking imatinib with another study drug.

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I am a woman able to have children and am not using strong birth control methods.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and until no patients are left on study, with an expected average of 20 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate long term safety data (SAEs and AEs)

Secondary study objectives

To evaluate clinical benefit as assessed by the investigator.

Side effects data

From 2013 Phase 1 & 2 trial • 14 Patients • NCT01281865

75%

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

Intra-abdominal hemorrhage

Constipation

Dyspnea

Papulopustular rash

Peripheral sensory neuropathy

Pneumonitis

Tumor pain

Anorexia

Cough

Hyponatremia

Skin and subcutaneous tissue disorders Other, specify-dry split fingernails

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1-Treatment (Everolimus and Imatinib Mesylate)

Arm 2-Treatment (Everolimus and Imatinib Mesylate)

Awards & Highlights

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.

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

0 / 5Eligibility criteria met