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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
Must not have
Known inherited predisposition to bleeding or thrombosis
Prior treatment with nintedanib or any other VEGFR inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each 28 day cycle for up to 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing a new drug called nintedanib combined with standard chemotherapy on patients with advanced pancreatic cancer. The goal is to see if this combination is safe and can be tolerated. Nintedanib works by blocking new blood vessels that tumors need to grow. Nintedanib, initially developed for cancer, has been recently approved for the treatment of a lung disease due to its ability to inhibit specific proteins.
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.
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.
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.
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I am 18 years old or older.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a genetic condition that affects my blood's ability to clot.
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I have previously been treated with nintedanib or similar drugs.
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I am not pregnant or breastfeeding.
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I have an active or chronic hepatitis B or C infection.
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My cancer has spread to the lining of my brain and spinal cord.
Select...
I have lost more than 20% of my body weight in the last 6 months or weigh less than 50 kg.
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My liver function tests are within the required range for my condition.
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I do not have serious heart conditions such as uncontrolled high blood pressure, recent heart attacks, severe heart failure, or dangerous irregular heartbeats.
Select...
I still have side effects from past cancer treatments.
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I do not have any serious infections requiring antibiotics.
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I have no active cancer other than in my pancreas.
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I do not have stomach or intestine problems that affect medication absorption.
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I have moderate to severe protein in my urine.
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My kidney function is reduced with creatinine above normal or GFR below 45.
Select...
I haven't fully healed from major injuries or surgeries in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each 28 day cycle for up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each 28 day cycle for up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD)
Side effects data
From 2021 Phase 3 trial • 752 Patients • NCT0161908513%
Cholelithiasis
13%
Myalgia
13%
Cataract
13%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (1199.32/.34)
Nintedanib 150 Bid (1199.35/.187)
Total (1199.32/.34/.35/.187)
Placebo (1199.187)
Nintedanib 100 Bid (1199.35)
Total (1199.35/.187)
Nintedanib 150 Bid (1199.32/.34)
Total (1199.32/.34)
Awards & Highlights
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.
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.
1. Nintedanib dose escalation: 150, 200 mg PO BID
2. Nab-paclitaxel: 125 mg/m2 day 1,8,15 every 28 days
3. 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Tyrosine kinase inhibitors (TKIs) like nintedanib target angiogenesis and tumor growth by inhibiting receptors such as VEGF, PDGF, and FGF, which are crucial for blood vessel formation and tumor proliferation.
This is significant for pancreatic cancer patients as it can potentially slow down tumor growth and spread. Other treatments, such as chemotherapy (e.g., gemcitabine and nab-paclitaxel), work by killing rapidly dividing cancer cells, while immunotherapy aims to boost the body's immune response against cancer cells.
Understanding these mechanisms helps in selecting the most effective treatment strategy tailored to the patient's specific cancer profile.
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
1,077 Previous Clinical Trials
1,056,047 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,546 Previous Clinical Trials
11,385,967 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
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