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Tyrosine Kinase Inhibitor
Nintedanib + Steroids for Radiation Pneumonitis
Phase 2
Waitlist Available
Led By Zachary Moore, MD
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
Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to CTCAE version 4.0 criteria
KPS > 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is studying nintedanib in combination with steroids to see if it's effective at treating IPF and what the side effects are. They will also look for markers in the blood that could predict worsening lung injury.
Who is the study for?
This trial is for adults over 18 with grade 2 or higher radiation pneumonitis after thoracic radiotherapy, who have certain types of cancer treated with intent to cure. They must be in good physical condition and not currently on high-dose steroids or other excluded treatments. Pregnant women, those at risk of bleeding or thrombosis, and patients with severe liver issues cannot participate.Check my eligibility
What is being tested?
The study tests the effects of Nintedanib combined with a decreasing dose of Prednisone on lung health in patients with radiation pneumonitis. It also looks for blood markers that might predict worsening lung injury and assesses how these treatments impact quality of life.See study design
What are the potential side effects?
Potential side effects include risks related to bleeding, liver problems, gastrointestinal issues like ulcers or perforation, increased protein in urine which can signal kidney trouble, and possible drug interactions affecting birth control efficacy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a severe lung condition after radiation.
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I am mostly independent in daily activities.
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My chest CT scan shows signs of lung inflammation from radiation.
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I am 18 years old or older.
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My side effects from radiation are mild.
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My cancer in the chest or breast area, lymphoma, or lung metastases was confirmed by a lab test and treated with the goal of curing it at MSK.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who are free from pulmonary exacerbations
Side effects data
From 2017 Phase 4 trial • 105 Patients • NCT0257960331%
Diarrhoea
16%
Dyspnoea
12%
Vomiting
12%
Nausea
12%
Fatigue
10%
Decreased appetite
8%
Abdominal pain upper
6%
Asthenia
6%
Dizziness
6%
Weight decreased
6%
Abdominal pain
6%
Contusion
6%
Cough
4%
Bronchitis
4%
Nasopharyngitis
2%
Gastrooesophageal reflux disease
2%
Atrial flutter
2%
Transient ischaemic attack
2%
Phlebitis
2%
Constipation
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Pyrexia
2%
Acute respiratory failure
2%
Pancreatitis acute
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nintedanib
Nintedanib + Pirfenidone
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo + PrednisoneExperimental Treatment2 Interventions
Placebo will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).
Group II: Nintedanib + PrednisoneExperimental Treatment2 Interventions
The initial dose of nintedanib will be 150mg two times per day orally according to study protocol. Nintedanib will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
2015
Completed Phase 4
~3680
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,587 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,505 Previous Clinical Trials
11,340,259 Total Patients Enrolled
Zachary Moore, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any major bleeding, clotting issues, or surgeries in the last year.Your liver tests show high levels of AST, ALT, or bilirubin.I had a blood clot within the last year before starting nintedanib.My scans show a tumor with cavities or dead tissue that is invading major blood vessels.I completed chest radiotherapy between 1 and 9 months ago.I have been diagnosed with a severe lung condition after radiation.I am mostly independent in daily activities.You have taken any experimental treatment within the 8 weeks before the screening visit.I am not taking specific drugs like azathioprine or on high dose anti-platelet therapy, and have not had a recent heart attack or unstable angina.I have a genetic tendency for blood clots.I have severe liver problems.I have had a hole in my stomach or intestines before.My chest CT scan shows signs of lung inflammation from radiation.I am 18 years old or older.I have been taking oral steroids for more than 4 weeks.I have brain metastases or leptomeningeal disease that hasn't been treated.My cancer has spread to my liver.My side effects from radiation are mild.I have no other cancers needing treatment, except for non-serious skin or bladder cancer.I am not pregnant, breastfeeding, and if able to bear children, I use effective birth control.I am a sexually active male not using birth control during the study.I am prone to bleeding easily.My cancer in the chest or breast area, lymphoma, or lung metastases was confirmed by a lab test and treated with the goal of curing it at MSK.My esophagus received more than 45 Gy of radiation.I have been diagnosed with diffuse radiation pneumonitis.I have a genetic tendency to bleed or form clots, and my blood clotting tests are abnormal.Your blood counts are too low: white blood cells less than 1.5 K/mcL, platelets less than 100 K/mcL, or hemoglobin less than 9.0 g/dl.I am not on any cancer treatments except for Pembrolizumab, Nivolumab, Afatinib, or hormonal therapies.My kidney function is impaired, with high protein levels or low filtration rate.I do not have stomach or intestine problems affecting medication absorption.I have an ongoing Hepatitis B or C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Nintedanib + Prednisone
- Group 2: Placebo + Prednisone
Awards:
This trial has 0 awards, including: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.
Has the Federal Drug Administration sanctioned Nintedanib for medical use?
"The safety of Nintedanib garnered a score of 2. This is because the drug has been through Phase 2 trials, indicating there are some data confirming its safety but none demonstrating efficacy."
Answered by AI
What other experiments have utilized Nintedanib to explore its potential therapeutic applications?
"Nintedanib was initially tested in 2001 at Providence Cancer Center of the Portland Medical Centre. As of now, 18946 trials have already been conducted and 351 are actively recruiting participants, with numerous studies being performed from Allentown, Pennsylvania."
Answered by AI
How many individuals have been accepted into this medical trial thus far?
"This trial is no longer receiving applications. It was first posted on July 1st, 2015 and the most recent update happened on July 19th, 2022. For those looking for other trials related to lung cancer, 594 studies are currently accepting participants; 351 of them focus specifically on Nintedanib therapy."
Answered by AI
Is recruitment for this research project still in progress?
"Unfortunately, this study is not presently accepting new participants. It was initially posted on July 1st 2015 and the last edit on its listing occurred on July 19th 2022. For those searching for other trials, there are 594 studies recruiting patients with lung cancer and 351 medical studies looking for people to test Nintedanib."
Answered by AI
How many locations are hosting this trial's operations?
"12 clinical trial sites are currently recruiting patients, with Lehigh Valley Health Network (Data Collection Only) in Allentown and Brigham and Women's Hospital (Data Collection Only) in Boston being two of the most prominent. Additionally, Memorial Sloan Kettering Westchester in Harrison is also part of this data collection initiative, as well as nine other locations."
Answered by AI
For what purposes is Nintedanib generally prescribed?
"Nintedanib is often prescribed for patients with thyroiditis and has additional applications in the treatment of ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."
Answered by AI
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