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Anti-metabolite

Regorafenib for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Sukhmani Padda
Research Sponsored by Stanford University
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 38 months
Awards & highlights

Study Summary

This trial is testing if combining regorafenib with methotrexate is effective in treating lung cancer that has spread and has a KRAS mutation.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Brain Metastasis
  • KRAS Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 38 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 38 months 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)
Secondary outcome measures
Disease Control Rate (DCR)
Maximum Serum Concentration (Cmax) of Methotrexate
Number of Participants With Adverse Events
+2 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: Treatment (regorafenib, methotrexate)Experimental Treatment3 Interventions
Participants receive regorafenib PO QD on days 1-21, and methotrexate PO twice weekly with 2-3 days apart on a 3 week on/ 1 week off cycle. 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
Methotrexate
2013
Completed Phase 4
~3800
Regorafenib
2014
Completed Phase 2
~1580

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,214 Total Patients Enrolled
Sukhmani PaddaPrincipal InvestigatorStanford University
Heather WakeleePrincipal InvestigatorStanford University
2 Previous Clinical Trials
13 Total Patients Enrolled

Frequently Asked Questions

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

What is the aggregate count of participants in this research?

"No, this clinical trial is not currently accepting any new candidates. It was initially posted on August 14th 2018 and last edited on February 9th 2022. If you're seeking other studies related to cancer, there are 4169 trials that require participants while 277 involve Regorafenib therapy specifically."

Answered by AI

What treatments does Regorafenib typically facilitate?

"Regorafenib is commonly administered to patients suffering from small cell lung cancer, active pauciarticular juvenile rheumatoid arthritis, and head and neck carcinoma."

Answered by AI

Is enrollment for this clinical investigation open to the public currently?

"This clinical trial has stopped recruiting participants as of February 9th, 2022. If you seek to join another medical study, there are currently 4169 cancer studies and 277 Regorafenib trials actively enrolling patients."

Answered by AI

Has the FDA given their stamp of approval to Regorafenib?

"Our team at Power rated Regorafenib as a 2 on the safety scale due to Phase 2 trial data indicating that while its security can be confirmed, there is yet no evidence of efficacy."

Answered by AI

What other inquests have been conducted involving Regorafenib?

"At this time, there are 277 active clinical trials analyzing the effects of Regorafenib with 74 in their third phase. Most of these studies take place in New york City; however, 8903 different sites offer research into Regorafenib."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer
Heather Wakelee 2018. "Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03520842.
~3 spots leftby Apr 2025
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