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Tyrosine Kinase Inhibitor
Nintedanib + Chemotherapy for Pancreatic Cancer
Phase 1 & 2
Waitlist Available
Led By Muhammad Beg, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No more than one prior line of non-gemcitabine/nab-paclitaxel containing systemic therapy for metastatic/locally advanced pancreatic cancer
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each 28 day cycle for 2 years
Awards & highlights
Study Summary
This trial will test if adding the drug nintedanib to standard chemotherapy can help treat pancreatic cancer by making use of DCE-MRI.
Who is the study for?
Adults over 18 with advanced pancreatic cancer who have not had more than one non-gemcitabine/nab-paclitaxel treatment for their condition. They must be able to perform daily activities with minimal assistance (ECOG score of 0-1) and have at least one measurable tumor lesion. Women must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the safety of Nintedanib combined with standard chemotherapy drugs, Gemcitabine and nab-Paclitaxel, in treating metastatic pancreatic cancer. It includes monitoring through DCE-MRI scans to assess how tumors respond.See study design
What are the potential side effects?
Possible side effects include typical reactions from chemotherapy such as nausea, fatigue, hair loss, low blood counts leading to increased infection risk or bleeding problems. Nintedanib may cause liver issues, high blood pressure, bleeding or clotting events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had only one treatment for advanced pancreatic cancer that didn't include gemcitabine or nab-paclitaxel.
Select...
I am 18 years old or older.
Select...
My cancer is a type of pancreatic cancer that has spread or is advanced.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each 28 day cycle for 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each 28 day cycle for 2 years
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 (MTD)
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
1Treatment groups
Experimental Treatment
Group I: Nintedanib MonotherapyExperimental Treatment1 Intervention
One cycle of Nintedanib monotherapy followed by a total of eight cycles of both Nintedanib and the chemotherapeutic agents, or until disease progression, whichever comes first.
Nintedanib dose escalation: 150, 200 mg PO BID
Nab-paclitaxel: 125 mg/m2 day 1,8,15 every 28 days
Gemcitabine: 1000 mg /m2 day 1,8,15 every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
FDA approved
Find a Location
Who is running the clinical trial?
South Plains Oncology ConsortiumNETWORK
6 Previous Clinical Trials
65 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,785 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,505 Previous Clinical Trials
11,340,278 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic condition that affects my blood's ability to clot.You are allergic to nintedanib, gemcitabine, nab-Paclitaxel, peanuts, soy, or any other trial drug ingredients.I had a biliary drain placed due to liver function issues caused by my cancer, and my liver tests are now within normal ranges.I have previously been treated with nintedanib or similar drugs.I do not have any serious illness or condition that could make this study unsafe for me.I am not pregnant or breastfeeding.There are signs of hollow or decaying tumors in the X-ray or imaging tests.I have an active or chronic hepatitis B or C infection.I've had only one treatment for advanced pancreatic cancer that didn't include gemcitabine or nab-paclitaxel.I have not had radiation on the cancer spot in the last 3 months.I have brain metastases that are either new, untreated, symptomatic, or not stable for more than 4 weeks.My cancer has spread to the lining of my brain and spinal cord.I have at least one tumor that can be measured.I am 18 years old or older.I am not pregnant and have taken a test in the last 14 days to confirm.I have lost more than 20% of my body weight in the last 6 months or weigh less than 50 kg.Your blood clotting tests show abnormalities that are higher than the normal range.My liver function tests are within the required range for my condition.I do not have serious heart conditions such as uncontrolled high blood pressure, recent heart attacks, severe heart failure, or dangerous irregular heartbeats.You are currently using alcohol or drugs excessively.I still have side effects from past cancer treatments.I do not have any serious infections requiring antibiotics.I have no active cancer other than in my pancreas.I've had more than one treatment for my advanced cancer, but not including early gemcitabine.My cancer is a type of pancreatic cancer that has spread or is advanced.I am fully active or can carry out light work.Your blood counts for infection-fighting white blood cells, platelets, and red blood cells are too low.I do not have stomach or intestine problems that affect medication absorption.I haven't had any major bleeding or blood clot events in the last 6 months.I have moderate to severe protein in my urine.I am on blood thinners that need regular INR checks, not including low-dose heparin or aspirin under 325mg.Things like mental health, family situation, where you live, or other factors that might make it hard for you to follow the study rules and appointments.My kidney function is reduced with creatinine above normal or GFR below 45.I haven't had cancer treatments like chemo or radiation (except for brain or limbs) in the last 4 weeks.I haven't fully healed from major injuries or surgeries in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Nintedanib Monotherapy
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT02902484 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other experiments involving Nintedanib that have been completed?
"Presently, 19 clinical trials are evaluating the efficacy of Nintedanib. Of those studies, 5 are in their final phase and 254 different medical centres throughout Chicago, Illinois are running these experiments."
Answered by AI
How many individuals are being accepted for inclusion in this trial?
"Unfortunately, the trial is not currently enrolling patients. It was first posted on September 7th 2017 and most recently updated on August 26th 2022. There are 578 trials for pancreatic cancer and 19 studies utilising nintedanib actively recruiting participants if you're seeking other clinical opportunities."
Answered by AI
Has this type of research ever been conducted prior to now?
"Nintedanib is presently being researched in 19 active trials across 53 cities and 30 nations. Way back in 2012, Boehringer Ingelheim sponsored a trial which enrolled 140 participants and completed both Phase 1 & 2 clinical studies. Since then, 91 more have been conducted."
Answered by AI
What ailments have been successfully addressed by Nintedanib?
"Typically, nintedanib is prescribed for patients suffering from adenocarcinoma. This medication can also be beneficial in treating metastatic non-small cell lung cancer due to adenocarcinoma and systemic scleroderma as well."
Answered by AI
Is this experiment accepting participants currently?
"According to the information hosted on clinicaltrials.gov, this medical study is not in need of new candidates at present time. Originally posted on September 7th 2017 and most recently updated August 26th 2022, this trial is currently inactive but there are 597 other trials that require participants right now."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I am 38 years male. recently diagnosed neuroendocrine carcinoma of pancreas, i want to enroll in any drug trial. please redirect me to the concerned authority.
PatientReceived 1 prior treatment
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