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Tyrosine Kinase Inhibitor

Regorafenib for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Gabriela Hobbs, MD
Research Sponsored by Massachusetts General Hospital
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 2 years
Awards & highlights

Study Summary

This trial is studying regorafenib as a possible treatment for advanced myeloid malignancies including AML (acute myeloid leukemia), MDS (myelodysplastic syndrome) and MPN (myeloproliferative neoplasms).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Maximum tolerated dose of regorafenib in patients with advanced myeloid malignancies
Secondary outcome measures
Overall Survival
Pharmacodynamic effects of regorafenib on cell signaling pathways
Progression Free Survival
+1 more

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%
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: RegorafenibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,339 Total Patients Enrolled
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,962 Total Patients Enrolled
Gabriela Hobbs, MDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
144 Total Patients Enrolled

Media Library

Regorafenib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03042689 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Regorafenib
Acute Myeloid Leukemia Clinical Trial 2023: Regorafenib Highlights & Side Effects. Trial Name: NCT03042689 — Phase 1

Frequently Asked Questions

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

What medical conditions is Regorafenib typically prescribed to treat?

"Regorafenib is the go-to medication for treating many anti-vegf related issues. Additionally, this drug can be beneficial in treating advanced directives, sorafenib, and unresectable gastrointestinal stromal tumor."

Answered by AI

What risks are associated with taking Regorafenib?

"Taking into consideration the experimental nature of this study, with few data points attesting to its efficacy and safety, Regorafenib has been assigned a score of 1."

Answered by AI

Are there still openings for volunteers in this clinical trial?

"This trial has concluded its recruitment phase as of September 4th, 2020. Initially posted on April 17th 2017, this study is no longer accepting patients for their clinical research. For those who are still looking to join an ongoing medical trial there are currently 508 studies enrolling participants with leukemia and 59 trials recruiting people undergoing treatment with regorafenib."

Answered by AI

Is this pioneering research a unique endeavor?

"Research into regorafenib has spanned since 2014, when the original Bayer-sponsored trial was conducted with 38 participants. Subsequent trials have seen the drug receive Phase 2 approval and 59 active studies across 418 cities and 30 countries."

Answered by AI

Have there been any other experiments conducted on Regorafenib?

"Presently, 59 trials are underway exploring the efficacy of Regorafenib. Of those studies, 7 have achieved Phase 3 status. A majority of these tests for this treatment take place in Commack, New york; though there are over 1200 sites running investigations with it worldwide."

Answered by AI

What is the current recruitment figure for this trial?

"This research project is not currently recruiting potential participants. The posting was initially made on April 17th 2017 and revised lastly in September 4th 2020. If you are seeking alternative trials, presently there are 508 studies with open enrollment for patients suffering from leukaemia, myelocytic acute and 59 clinical trials requiring Regorafenib volunteers."

Answered by AI
~2 spots leftby Apr 2025