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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 belowSelect...
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.
Select...
I do not have unstable chest pain.
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I have no allergies to sorafenib or similar drugs.
Select...
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:Select...
I am not taking certain seizure medications, St. John's wort, or Rifampin.
Select...
I am on warfarin, but it doesn't meet the trial's criteria.
Select...
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
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 • NCT0206618173%
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
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Hemorrhoids
2%
Blurred vision
2%
Hypothyroidism
2%
Urticaria
2%
Acute kidney injury
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
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
2015
Completed Phase 3
~3680
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,112,059 Total Patients Enrolled
Hedy L KindlerPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
1 Previous Clinical Trials
118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any blockage or holes in my intestines.I have never taken medication to stop new blood vessels from forming in my tumor.I haven't had immunotherapy after my last dose of imatinib or sunitinib.I am not taking certain seizure medications, St. John's wort, or Rifampin.I do not have heart failure symptoms.My blood pressure is under control.I am on warfarin, but it doesn't meet the trial's criteria.I am on HIV medication.I do not have an irregular heartbeat.I do not have any current infections.I do not have any uncontrolled illnesses.My cancer is a confirmed gastrointestinal stromal tumor.I do not have unstable chest pain.I have no allergies to sorafenib or similar drugs.My condition cannot be cured with surgery.My tumor tests positive for the KIT protein.My condition worsened after treatment with imatinib and sunitinib.I have a tumor that can be measured and is larger than 20 mm or 10 mm on a CT scan.My measurable cancer is not in an area that has been previously treated with radiation.I do not have cancer that has spread to my brain.I am able to get out of my bed or chair and move around.I haven't taken any experimental drugs since my last dose of imatinib or sunitinib.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 5 years.It has been over 2 weeks since my last imatinib or sunitinib treatment.I have never taken sorafenib.I have not taken drugs targeting the MAPK pathway.I haven't had chemotherapy or chemoembolization after my last dose of imatinib mesylate or sunitinib malate.It's been over 4 weeks since my last radiotherapy and I've recovered.I am not currently receiving any other cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sorafenib tosylate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.