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Multi-kinase inhibitor

Sorafenib for Gastrointestinal Stromal Tumor

Phase 2

Waitlist Available

Led By Hedy L Kindler

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence of bowel perforation or obstruction

No prior angiogenesis inhibitors

Must not have

Concurrent administration of enzyme-inducing antiepileptic drugs, Hypericum perforatum (St. John's wort), or Rifampin

Concurrent anticoagulation therapy with warfarin not meeting specified criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying sorafenib for treating patients with gastrointestinal stromal tumor that progressed after treatment with imatinib and sunitinib.

Who is the study for?

This trial is for patients with a type of cancer called gastrointestinal stromal tumor (GIST) that has worsened despite treatment with imatinib mesylate and sunitinib malate. Participants must have measurable disease, no brain metastases, acceptable organ function, controlled blood pressure, not be pregnant or nursing, and agree to use contraception. They should not have other active cancers or serious medical conditions.

What is being tested?

The trial is testing the effectiveness of Sorafenib Tosylate in treating GIST that hasn't responded to standard treatments. Sorafenib aims to inhibit enzymes necessary for cancer cell growth and cut off the tumor's blood supply.

What are the potential side effects?

Sorafenib may cause side effects such as high blood pressure, bleeding problems, heart issues like chest pain or heart attack, skin reactions at the drug application site or throughout the body, digestive disturbances like diarrhea or constipation, fatigue and weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any blockage or holes in my intestines.

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I have never taken medication to stop new blood vessels from forming in my tumor.

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I do not have heart failure symptoms.

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My blood pressure is under control.

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I do not have an irregular heartbeat.

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I do not have any current infections.

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My cancer is a confirmed gastrointestinal stromal tumor.

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I do not have unstable chest pain.

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I have no allergies to sorafenib or similar drugs.

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My condition cannot be cured with surgery.

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My tumor tests positive for the KIT protein.

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My condition worsened after treatment with imatinib and sunitinib.

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I have a tumor that can be measured and is larger than 20 mm or 10 mm on a CT scan.

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My measurable cancer is not in an area that has been previously treated with radiation.

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I do not have cancer that has spread to my brain.

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I am able to get out of my bed or chair and move around.

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I haven't taken any experimental drugs since my last dose of imatinib or sunitinib.

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I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 5 years.

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I have never taken sorafenib.

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I have not taken drugs targeting the MAPK pathway.

Exclusion Criteria

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

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I am not taking certain seizure medications, St. John's wort, or Rifampin.

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I am on warfarin, but it doesn't meet the trial's criteria.

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I am on HIV medication.

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I am not currently receiving any other cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Objective Response Rate

Secondary study objectives

Overall Survival

Progression-free Survival

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181

73%

Fatigue

71%

Palmar-plantar erythrodysesthesia syndrome

63%

Hypertension

61%

Papulopustular rash

55%

Diarrhea

51%

Nausea

39%

Myalgia

37%

Alopecia

35%

Arthralgia

33%

Abdominal pain

31%

Anorexia

27%

Vomiting

22%

Mucositis oral

22%

Constipation

18%

Anemia

18%

Alanine aminotransferase increased

16%

Platelet count decreased

14%

Pruritus

14%

Hyperglycemia

14%

Rash maculo-papular

14%

Skin and subcutaneous tissue disorders - Other, specify

12%

Aspartate aminotransferase increased

12%

Rash acneiform

12%

Peripheral sensory neuropathy

10%

Investigations - Other, specify

10%

Dry skin

10%

Neutrophil count decreased

10%

Blood bilirubin increased

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Blurred vision

Hypothyroidism

Urticaria

Hemorrhoids

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Sorafenib Tosylate)

Arm II (Placebo)

Crossover Group

Awards & Highlights

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: Treatment (sorafenib tosylate)Experimental Treatment1 Intervention

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sorafenib Tosylate

2005

Completed Phase 3

~4010

0 / 24Eligibility criteria met