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Multi-kinase inhibitor

Regorafenib for Adenoid Cystic Carcinoma

Phase 2
Waitlist Available
Led By Alan Ho, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
ECOG performance status ≤ 2 (Karnofsky ≥ 60%,).
Must not have
Concurrent use of strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole) or strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort).
Active or clinically significant cardiac disease including:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing regorafenib, a pill that can stop cancer cells from growing and reduce their blood supply, in patients with adenoid cystic carcinomas. The study aims to see if this medication can be effective for these patients.

Who is the study for?
Adults with confirmed adenoid cystic carcinoma that's recurrent or spread and not treatable by surgery or radiotherapy. They must have measurable disease, no recent severe side effects from past treatments, and be in relatively good health with a life expectancy of at least 3 months. Pregnant women can't participate, and those who can have children must use contraception.
What is being tested?
The trial is testing Regorafenib, an oral drug that may slow cancer growth. Initially given at lower than the FDA-approved dose for other cancers to reduce side effects, the dose may increase if well-tolerated after one month.
What are the potential side effects?
Regorafenib might cause high blood pressure, bleeding problems, heart issues like chest pain or heart attack within the last six months, liver problems beyond certain limits set by the study criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or spread and cannot be removed by surgery or cured with radiation.
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I can take care of myself but might not be able to do active work.
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I am 18 years old or older.
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My amylase and creatinine levels are within normal limits.
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I can swallow and keep down pills.
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I have a tumor that can be measured with scans.
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My liver function tests are within the required range.
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My blood counts meet the required levels without transfusions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking strong medication inhibitors or inducers like rifampin or ketoconazole.
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I do not have any serious heart conditions.
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I have untreated heart artery disease.
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I am on medication for heart rhythm problems not managed by beta blockers or digoxin.
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I have HIV or hepatitis B/C that needs antiviral treatment.
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I currently have symptoms of interstitial lung disease.
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My high blood pressure is not controlled even with medication.
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I have not had severe bleeding in the last 4 weeks.
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I have been diagnosed with phaeochromocytoma.
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I do not have an infection that would stop me from receiving the study treatment.
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I have a wound or ulcer that hasn’t healed, but it’s not caused by cancer.
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I have had an organ transplant.
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I am not pregnant or breast-feeding.
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I have previously taken regorafenib.
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I am not using any herbal remedies like St. John's wort.
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I have a history of bleeding disorders.
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I require dialysis for kidney failure.
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I am on medication for seizures.
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I have a condition that affects how my body absorbs nutrients.
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My heart condition is not severe and is classified below NYHA Class III.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
best overall response rate
patients alive without disease progression
Secondary study objectives
Safety

Side effects data

From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607
82%
Diarrhoea
76%
Nausea
71%
Fatigue
57%
Vomiting
53%
Abdominal pain
30%
Neuropathy peripheral
27%
Dyspnoea
25%
Anaemia
23%
Neutrophil count decreased
23%
Constipation
22%
Weight decreased
21%
Hypokalaemia
20%
Oedema peripheral
18%
Dehydration
17%
Cough
17%
Neutropenia
17%
Pyrexia
17%
Peripheral sensory neuropathy
16%
Thrombocytopenia
15%
Platelet count decreased
15%
Back pain
13%
Mucosal inflammation
13%
Temperature intolerance
13%
Dysgeusia
13%
Chromaturia
12%
White blood cell count decreased
12%
Urinary tract infection
11%
Dizziness
11%
Depression
10%
Hyponatraemia
10%
Stomatitis
10%
Ascites
10%
Dysphagia
10%
Anxiety
9%
Headache
9%
Abdominal distension
9%
Insomnia
8%
Arthralgia
8%
Asthenia
8%
Pain in extremity
8%
Alopecia
7%
Urine ketone body present
7%
Blood alkaline phosphatase increased
7%
Pulmonary embolism
6%
Lymphopenia
6%
Leukopenia
6%
Blood bilirubin increased
6%
Dyspepsia
5%
Sepsis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Urine leukocyte esterase positive
5%
Abdominal pain upper
5%
Gastrooesophageal reflux disease
5%
Proteinuria
5%
Rash
4%
Flatulence
4%
Chills
3%
Dry mouth
3%
Myalgia
3%
Epistaxis
3%
Muscle spasms
2%
Pneumonia
2%
pelvic fracture
2%
Haematemesis
2%
Disease progression
2%
Pleural effusion
2%
Confusional state
2%
Mental status changes
2%
malignant neoplasm progression
1%
Large intestine perforation
1%
Oesophagitis
1%
Lung abscess
1%
embolism
1%
pancreatic carcinoma
1%
fall
1%
Death
1%
Haemorrhage intranial
1%
Atrial fibrillation
1%
Colitis
1%
Enterocutaneous fistula
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
somnolence
1%
syncope
1%
Febrile neutropenia
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Hypoxia
1%
Pneumonia aspiration
1%
Clostridium difficile colitis
1%
Influenza
1%
Perirectal abscess
1%
Salmonella sepsis
1%
Septic shock
1%
hip fracture
1%
deep vein thrombosis
1%
haematoma
1%
pelvic venous thrombosis
1%
Cholangitis
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX

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: patients with adenoid cystic carcinomaExperimental Treatment1 Intervention
This is a single-arm phase II study of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (R/M ACC) treated with regorafenib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1630

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Adenoid Cystic Carcinoma (ACC) include surgery, radiation therapy, and targeted therapies such as tyrosine kinase inhibitors. Regorafenib, a tyrosine kinase inhibitor, works by interfering with cancer cell growth and reducing the formation of blood vessels around tumors, which is crucial for tumor survival and metastasis. This mechanism is particularly important for ACC patients because it targets the pathways that contribute to the aggressive nature of the cancer, potentially improving outcomes by inhibiting tumor growth and spread.
Regorafenib Reverses Temozolomide-Induced CXCL12/CXCR4 Signaling and Triggers Apoptosis Mechanism in Glioblastoma.Regorafenib sensitizes human breast cancer cells to radiation by inhibiting multiple kinases and inducing DNA damage.Z-360 Suppresses Tumor Growth in MIA PaCa-2-bearing Mice <i>via</i> Inhibition of Gastrin-induced Anti-Apoptotic Effects.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,913 Total Patients Enrolled
BayerIndustry Sponsor
2,270 Previous Clinical Trials
25,508,694 Total Patients Enrolled
Alan Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
239 Total Patients Enrolled

Media Library

Regorafenib (Multi-kinase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02098538 — Phase 2
Adenoid Cystic Carcinoma Research Study Groups: patients with adenoid cystic carcinoma
Adenoid Cystic Carcinoma Clinical Trial 2023: Regorafenib Highlights & Side Effects. Trial Name: NCT02098538 — Phase 2
Regorafenib (Multi-kinase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02098538 — Phase 2
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