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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%,).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will help researchers learn if regorafenib is a safe and effective treatment option for adenoid cystic carcinoma.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
best overall response rate
patients alive without disease progression
Secondary outcome measures
Safety
Side effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT0202460782%
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%
Lung abscess
1%
pancreatic carcinoma
1%
Oesophagitis
1%
Large intestine perforation
1%
embolism
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
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
~1580
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,582 Total Patients Enrolled
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,940 Total Patients Enrolled
Alan Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
239 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong medication inhibitors or inducers like rifampin or ketoconazole.I do not have any serious heart conditions.I am not on any cancer treatments except for bone metastases medication.I have not had major surgery or a significant injury in the last 28 days.I have untreated heart artery disease.I am on medication for heart rhythm problems not managed by beta blockers or digoxin.I have HIV or hepatitis B/C that needs antiviral treatment.I have a wound or ulcer that hasn’t healed, but it’s not caused by cancer.I have had an organ transplant.I am not pregnant or breast-feeding.I haven't had a stroke, clot, or embolism in the last 6 months.I have had cancer before, but it won't affect this trial.I have previously taken regorafenib.I am not using any herbal remedies like St. John's wort.My cancer has returned or spread and cannot be removed by surgery or cured with radiation.I can take care of myself but might not be able to do active work.It's been over 2 weeks since my last cancer treatment, and I've recovered from the side effects.I have a history of bleeding disorders.I require dialysis for kidney failure.I am on medication for seizures.I have a condition that affects how my body absorbs nutrients.I can swallow and keep down pills.My blood, liver, and kidney tests are within normal ranges.I am receiving radiation for symptom relief, not to cure my cancer.I am 18 years old or older.My amylase and creatinine levels are within normal limits.My heart condition is not severe and is classified below NYHA Class III.My scans show new or worsening cancer spots within the last 6 months.I agree to a biopsy unless it's deemed too risky or unnecessary by a doctor.I have a tumor that can be measured with scans.I currently have symptoms of interstitial lung disease.My liver function tests are within the required range.My blood counts meet the required levels without transfusions.I have not had severe bleeding in the last 4 weeks.I do not have an infection that would stop me from receiving the study treatment.My high blood pressure is not controlled even with medication.My cancer is confirmed as adenoid cystic carcinoma, even if it didn't start in the salivary glands.I have been diagnosed with phaeochromocytoma.I am not pregnant and have taken a test in the last 2 weeks to confirm this, or I am post-menopausal or surgically sterilized.I have not had a heart attack or unstable chest pain recently.I do not have symptoms from brain or spinal cord tumor spread.My blood thinner medication is stable and monitored if it's a Vitamin-K antagonist.
Research Study Groups:
This trial has the following groups:- Group 1: patients with adenoid cystic carcinoma
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.
At what number of sites is this clinical experiment being conducted?
"At present, this experimental trial is recruiting participants from 5 different sites. Those who are interested may be able to find a site in Basking Ridge, Rockville Centre, or Commack which would reduce the need for extensive travel if they choose to participate."
Answered by AI
What therapeutic application is Regorafenib most commonly employed for?
"Those who have been given anti-vegf treatments may gain relief from regorafenib, which is also an effective tool to manage advanced directives, sorafenib, and unresectable gastrointestinal stromal tumors."
Answered by AI
Has the U.S. Food & Drug Administration certified Regorafenib?
"Regorafenib's safety rating measures a 2, signifying that there is supportive data on its safety but not yet any research-backed evidence of efficacy."
Answered by AI
What conclusions have been drawn from prior experiments involving Regorafenib?
"Memorial Sloan Kettering Cancer Center initiated the first clinical trial of regorafenib in 2014, and since then there have been 82 completed studies. Currently, 58 more trials are underway with a majority being conducted out of Basking Ridge, New jersey."
Answered by AI
Is this the pioneering endeavor of its sort?
"Research into Regorafenib was initiated in 2014, with the first clinical trial backed by Bayer. After successful completion of Phase 1 and 2 trials involving 38 patients respectively, it has been granted approval for use in medication today. Currently there are 58 active research studies spanning 418 cities across 30 countries researching its efficacy."
Answered by AI
Is there room for additional participants in the experiment?
"Unfortunately, this particular clinical trial has stopped accepting applications. It was first published on March 1st 2014 and last edited April 26th 2022. If you're still looking for research studies, there are presently 2470 trials in search of participants with carcinoma or adenoid cystic issues; 58 studies actively recruiting patients to test Regorafenib as well."
Answered by AI
How many participants is the clinical trial recruiting?
"Unfortunately, this study is no longer searching for participants. The trial first appeared on March 1st 2014 and was updated most recently on April 26th 2022. If you are seeking other clinical trials related to carcinoma, adenoid cystic or Regorafenib specifically there are 2470 active studies recruiting patients and 58 enrolment programmes involving the latter medication."
Answered by AI
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