Nintedanib for Cancer of Pancreas

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Texas Southwestern Medical Center, Dallas, TX
Cancer of Pancreas+1 More
Nintedanib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

This study is evaluating whether a drug may help improve the effectiveness of chemotherapy for individuals with pancreatic cancer.

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Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Nintedanib will improve 1 primary outcome in patients with Cancer of Pancreas. Measurement will happen over the course of Each 28 day cycle for 2 years.

Year 2
Maximum Tolerated Dose (MTD)

Trial Safety

Side Effects for

Nintedanib + Pirfenidone
Nausea
42%
Diarrhoea
38%
Vomiting
28%
Fatigue
19%
Abdominal pain upper
13%
Headache
13%
Decreased appetite
11%
Bronchitis
9%
Nasopharyngitis
8%
Abdominal pain
8%
Cough
8%
Abdominal discomfort
8%
Weight decreased
8%
Pyrexia
6%
Dysgeusia
6%
Hepatocellular injury
6%
Alanine aminotransferase increased
6%
Constipation
6%
Gamma-glutamyltransferase increased
6%
Photosensitivity reaction
6%
Gastrooesophageal reflux disease
6%
Aspartate aminotransferase increased
6%
Dyspnoea
4%
Asthenia
2%
Pneumonia
2%
Idiopathic pulmonary fibrosis
2%
Circulatory collapse
2%
Phlebitis
0%
Transient ischaemic attack
0%
Pancreatitis acute
0%
Acute respiratory failure
0%
Dizziness
0%
Contusion
0%
Atrial flutter
0%
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02579603) in the Nintedanib + Pirfenidone ARM group. Side effects include: Nausea with 42%, Diarrhoea with 38%, Vomiting with 28%, Fatigue with 19%, Abdominal pain upper with 13%.

Trial Design

2 Treatment Groups

Control
Nintedanib Monotherapy

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nintedanib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Nintedanib Monotherapy
Drug
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
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: each 28 day cycle for 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly each 28 day cycle for 2 years for reporting.

Closest Location

University of Texas Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects with at least one measurable disease lesion at baseline as assessed by RECIST, version 1.1. show original
for patients with locally advanced disease, who have had no response to gemcitabine or who have progressive disease after 4 months of treatment, who are not eligible for curative surgery A person has histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas show original
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1 indicates a patient who is asymptomatic and has no evidence of disease. show original
Any woman of childbearing potential must have a negative pregnancy test before they register for the study show original
The patient's liver function tests may be included in the study if they develop during the workup and are the result of a mechanical obstruction of the biliary drainage by tumor compression or invasion show original
Participants signed a form agreeing to participate in the study prior to admission. show original
Age ≥ 18 years;
"For metastatic or locally advanced pancreatic cancer, patients should only receive one other line of systemic therapy before receiving gemcitabine/nab-paclitaxel. show original
Having certain biological measurements at the beginning of the study (taken within two weeks of registering for the study). show original

Patient Q&A Section

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

What are common treatments for cancer of pancreas?

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The data suggest common treatments and procedures: 1. Chemotherapy; 2. Surgery; 3. Radiation; 4. Supportive care. The most likely reason for common treatments might be the fact, that they are considered standard treatment with the best cure outcomes, even if there is some degree of toxicity.

Unverified Answer

Can cancer of pancreas be cured?

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Cancers of pancreatic ductal (pancreatic adenocarcinoma and intraductal mucinous adenocarcinoma ) and pancreatic head (both pancreatic adenocarcinoma and squamous cell carcinoma or mixed type of adenocarcinoma) seem to have no possibility of curative treatment as of 2014. And we cannot make the curative treatment for cancer of pancreatic ductal.

Unverified Answer

What causes cancer of pancreas?

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The combination of obesity, a family history of pancreatic cancer, type 2 diabetes, and smoking is the leading risk factor for developing pancreatic cancer; the genetic and environmental factors mentioned here can only be implemented into prediction models.

Unverified Answer

What is cancer of pancreas?

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Pancreatic cancer often presents with weight loss, jaundice and pain in the upper abdomen. The overall five-year survival rate for pancreatic cancer is between 9% and 29%. Tumours that have produced symptoms of jaundice and pancreatobiliary pain can often be successfully surgically removed; however, treatment of symptoms caused by malignancy is less successful. More importantly, patients with pancreatic cancer suffer from malnutrition and often have poor oral intakes which can lead to malnutrition. Therefore, proper nutritional care is essential to aid survival.

Unverified Answer

How many people get cancer of pancreas a year in the United States?

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About 80,000 cases of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) are diagnosed a year in the United States. This makes it the 10th most common type of cancer, and the 2nd most common cause of death in US men over the age of 45.

Unverified Answer

What are the signs of cancer of pancreas?

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The most commonly presenting signs of pancreatic cancer are jaundice, jumbled stomach, abdominal pain and a mass. There may be evidence of blood-clotting in the head of the pancreas.

Unverified Answer

What are the common side effects of nintedanib?

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Nintedanib was generally well-tolerated across all types of cancer. With the number of deaths that occur after stopping treatment, it is important for patients to carefully report side effects to their treating physician. The most common common side effects are diarrhea, headaches, rash, nausea, insomnia, and fatigue. Treatments to manage these side effects should be provided as necessary.

Unverified Answer

Has nintedanib proven to be more effective than a placebo?

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The addition of nintedanib (vs placebo) in pancreatic cancers did not result in a greater percentage of objective responses or prolongation of progression-free survival compared with placebo. Nintedanib is not a more active drug option in patients with pancreatic cancer. (Int J Gastrop., 2016;16:119-132).

Unverified Answer

What is the primary cause of cancer of pancreas?

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[If you are looking to join a pancreatic cancer clinical trial, Power can help you search recent trials by condition, treatment, or location.] Pancreatic cancer was first described in 1843 by German pathologist Richard von Stilling (1800-1879). Today, pancreatic cancer is the third most common cause of cancer-related deaths in the UK (13,100 cases were diagnosed in 2007). If you have had a pancreaticoduodenectomy (surgery to remove part of your small intestine and the pancreas), you should be considered a potential pancreatic cancer patient.

Unverified Answer

What is nintedanib?

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The study demonstrates that nintedanib has clinical therapeutic value at inhibiting tumor growth and prolonging PFS in the treatment of advanced non-small cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)(NSCLC), gastric cancer and in a number of other tumors, which will help identify and develop drug candidates for further evaluation in cancer.

Unverified Answer

Have there been other clinical trials involving nintedanib?

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All the patients have been prescribed nintedanib and have a disease course of some years. It can be concluded that trials with different chemotherapy agents for advanced pancreatic cancer are necessary. Results from a recent clinical trial should not preclude the use of a chemotherapeutic agent (like nintedanib) as a treatment of last resort, after repeated failures of drugs like gemcitabine, irinotecan, pemetrexed, or erlotinib.

Unverified Answer

What is the survival rate for cancer of pancreas?

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The overall five-year survival rate with aggressive surgery was about 90%; the survival for Stage IV patients may be significantly improved with a higher percentage of unresectable patients.

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