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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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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.
Select...
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.
Select...
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
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%
Blurred vision
2%
Acute kidney injury
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
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
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,115 Total Patients Enrolled
Hedy L KindlerPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current sample size for this experiment?
"This clinical trial is now closed to new participants. It was first posted on September 14th 2005, and last updated November 16th 2022. For those seeking other studies related to gastrointestinal stromal tumors, there are currently 41 active trials recruiting patients; alternatively, 59 medical studies for Sorafenib Tosylate are also actively enrolling individuals."
Answered by AI
What medical conditions are typically treated with Sorafenib Tosylate?
"Sorafenib Tosylate is prescribed to treat progressive, metastatic radioactive iodine-refractory differentiated thyroid carcinoma (dtc) as well as gastrointestinal stromal tumors, hemangiosarcoma and leiomyosarcoma."
Answered by AI
Has Sorafenib Tosylate been granted authorization by the FDA?
"According to our evaluation at Power, Sorafenib Tosylate was assigned a score of 2 in terms of safety. This is because the clinical trial only has evidence regarding its security but not it's effectiveness."
Answered by AI
Are there any precedent research studies that have utilized Sorafenib Tosylate?
"Initially researched in 2005 at the Central Illinois Hematology Oncology Center, sorafenib tosylate has been further studied 397 times. At present, 59 active trials are occurring throughout various areas - particularly in Sacramento, California."
Answered by AI
Is enrollment for this experiment currently open?
"This research initiative has concluded its recruitment process as the most recent update to this trial was posted on November 16th 2022. If participants are in search of new trials, there are currently 41 studies for gastrointestinal stromal tumors and 59 Sorafenib Tosylate-related initiatives actively recruiting members."
Answered by AI
What is the geographic scope of this research endeavor in the United States?
"There are a total of 6 clinics offering this clinical trial, including the University of California Davis Comprehensive Cancer Center in Sacramento, Memorial Sloan Kettering Cancer Center in New york and the University of Chicago Comprehensive Cancer Center in Chicago. Additionally, there exist 3 more sites to choose from."
Answered by AI
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