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Kinase Inhibitor

Sorafenib Tosylate for Desmoid Tumor

Phase 3
Waitlist Available
Led By Mrinal M Gounder
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing whether a drug called sorafenib tosylate can help treat patients with desmoid tumors or aggressive fibromatosis.

Eligible Conditions
  • Desmoid Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival(PFS) Rate
Secondary outcome measures
Best Objective Status Between the Two Treatment Arms According to Response Evaluation Criteria in Solid Tumors Version 1.1
Duration of Response
Incidence of Adverse Events, Using the Patient Reported Outcomes-Common Terminology Criteria in Adverse Events Version 4.0
+2 more
Other outcome measures
Cadherin-associated Protein, Beta 1 (CTNNB1) Genotype (Correlative Companion Study-A091105-ST1 Study)
Changes in Immunohistochemistry Score of Beta-catenin Cytoplasm/Nuclear Ratio (Correlative Companion Study- A091105-ST1 Study)
Body Weight Changes
+9 more

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
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%
Acute kidney injury
2%
Blurred vision
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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (sorafenib tosylate)Experimental Treatment3 Interventions
Patients receive sorafenib tosylate PO QD on days 1-28.
Group II: Arm II (placebo)Placebo Group3 Interventions
Patients receive placebo PO QD on days 1-28. Patients may crossover to Arm I upon disease progression.
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
13,665 Previous Clinical Trials
40,925,767 Total Patients Enrolled
Mrinal M GounderPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Sorafenib Tosylate a new medication?

"There are 24 Sorafenib Tosylate trials in Phase 3 and 65 clinical trials in total. Out of these, many are situated in Taibei, Taiwan; however, there are 2804 locations running studies for Sorafenib Tosylate globally."

Answered by AI

Are recruitment efforts for this research still underway?

"Currently, this study is not recruiting patients. The most recent update to the trial was on July 1st, 2022 and it was first posted on March 21st, 2014. If you are looking for other studies, there are 22 trials related to fibromatosis and 65 trials involving Sorafenib Tosylate that are actively recruiting participants."

Answered by AI

How many test subjects are needed for this clinical trial?

"Unfortunately, this clinical trial is not currently looking for new patients. Although, it's important to note that the study was most recently edited on 7/1/2022. If you're interested in other trials, there are 65 different studies enrolling participants with fibromatosis and 22 more involving Sorafenib Tosylate."

Answered by AI

For what purpose is Sorafenib Tosylate most regularly prescribed?

"Sorafenib Tosylate can be used to target and treat progressive, metastatic radioactive iodine-refractory differentiated thyroid carcinoma (dtc), gastrointestinal stromal tumors, and hemangiosarcoma."

Answered by AI

What has been the FDA's response to Sorafenib Tosylate?

"Sorafenib Tosylate is a phase 3 trial medication, so it has received a score of 3 for safety. This reflects the presence of both efficacy data and multiple rounds of safe clinical trials."

Answered by AI

Where are the sites of this clinical trial?

"A few of the 100+ locations where this trial is running include Health Partners Inc in Minneapolis, Minnesota, Park Nicollet Clinic - Saint Louis Park in Saint Louis Park, Delaware, and Beebe Medical Center in Lewes, Hawaii."

Answered by AI
Recent research and studies
Quality of Life ResearchJournal
Missing Data Strategies for the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2
Mazza, Gina L., Molly M. Petersen, Brenda Ginos, Blake T. Langlais, Narre Heon, Mrinal M. Gounder, Michelle R. Mahoney, et al.. 2021. “Missing Data Strategies for the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/s11136-021-02968-1.
Clinical TrialsJournal
Composite Grading Algorithm for the National Cancer Institute’s Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Basch, Ethan, Claus Becker, Lauren J Rogak, Deborah Schrag, Bryce B Reeve, Patricia Spears, Mary Lou Smith, et al.. 2020. “Composite Grading Algorithm for the National Cancer Institute’s Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)”. Clinical Trials. SAGE Publications. doi:10.1177/1740774520975120.
New England Journal of MedicineJournal
Sorafenib for Advanced and Refractory Desmoid Tumors
Gounder, Mrinal M., Michelle R. Mahoney, Brian A. Van Tine, Vinod Ravi, Steven Attia, Hari A. Deshpande, Abha A. Gupta, et al.. 2018. “Sorafenib for Advanced and Refractory Desmoid Tumors”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1805052.
Quality of Life ResearchJournal
Missing Data Strategies for the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2
Mazza, Gina L., Molly M. Petersen, Brenda Ginos, Blake T. Langlais, Narre Heon, Mrinal M. Gounder, Michelle R. Mahoney, et al.. 2021. “Missing Data Strategies for the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/s11136-021-02968-1.
~8 spots leftby Apr 2025
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