What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as tyrosine kinase inhibitors (TKIs) like nintedanib and standard chemotherapy regimens (gemcitabine and nab-paclitaxel), have several known side effects. TKIs often cause hepatotoxicity, gastrointestinal issues (diarrhea, nausea), fatigue, and cardiovascular effects. Chemotherapy can lead to neutropenia, anemia, thrombocytopenia, fatigue, and gastrointestinal symptoms. Combining these treatments may increase the risk of these adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including tyrosine kinase inhibitors like sunitinib, which targets angiogenesis and tumor growth. Sunitinib has shown efficacy in treating advanced pancreatic neuroendocrine tumors by inhibiting multiple receptor tyrosine kinases involved in tumor proliferation and angiogenesis. Other approved treatments include chemotherapy agents such as gemcitabine and nab-paclitaxel, which are often used in combination to enhance therapeutic outcomes. These treatments aim to slow disease progression and improve survival rates in patients with advanced pancreatic cancer.

What other types of research exist?

Promising alternatives to Nintedanib for pancreatic cancer patients include: 1) Larotrectinib and Entrectinib, which target TRK fusion-positive tumors; 2) Dabrafenib plus Trametinib for BRAFV600E-mutated tumors; 3) Selpercatinib for RET fusion-positive tumors; and 4) Immunotherapy agents like Pembrolizumab for tumors with high microsatellite instability or mismatch repair deficiency. These therapies have shown efficacy in various solid tumors and may offer new hope for pancreatic cancer patients.

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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 below

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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:

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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.

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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.

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and each 28 day cycle for up to 2 years for reporting.

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 • NCT01619085

69%

Diarrhoea

22%

Cough

20%

Idiopathic pulmonary fibrosis

20%

Nasopharyngitis

19%

Bronchitis

19%

Nausea

16%

Weight decreased

16%

Dyspnoea

15%

Upper respiratory tract infection

14%

Decreased appetite

13%

Pneumonia

12%

Vomiting

Fatigue

Abdominal pain

Constipation

Back pain

Hypertension

Oedema peripheral

Arthralgia

Pulmonary hypertension

Abdominal pain upper

Pyrexia

Respiratory tract infection

Headache

Dizziness

Chest pain

Respiratory failure

Asthenia

Lower respiratory tract infection

Rhinitis

Insomnia

Productive cough

Influenza

Cataract

Myalgia

Anxiety

Pulmonary fibrosis

Hypoxia

Pneumothorax

Pulmonary embolism

Acute respiratory failure

Lung neoplasm malignant

Cardiac failure

Hepatic enzyme increased

Haemoptysis

Cor pulmonale

Coronary artery disease

Right ventricular failure

Haemorrhoids

Inguinal hernia

Pancreatitis

Multiple organ dysfunction syndrome

Sudden death

Cholelithiasis

Sepsis

Urinary tract infection

Fall

Femur fracture

Basal cell carcinoma

Lung adenocarcinoma

Prostate cancer

Small cell lung cancer

Squamous cell carcinoma

Squamous cell carcinoma of skin

Pulmonary arterial hypertension

Acute myocardial infarction

Angina pectoris

Gastrointestinal haemorrhage

Rib fracture

Syncope

Atrial fibrillation

Cardiac arrest

Myocardial ischaemia

Cholecystitis acute

Pneumonia bacterial

Dehydration

Transient ischaemic attack

Acute kidney injury

Benign prostatic hyperplasia

Interstitial lung disease

Pulmonary oedema

Cardiac failure congestive

Myocardial infarction

Coronary artery stenosis

Renal failure

100%

80%

60%

40%

20%

Study treatment Arm

Total (1199.32/.34/.35/.187)

Nintedanib 150 Bid (1199.35/.187)

Placebo (1199.187)

Total (1199.35/.187)

Total (1199.32/.34)

Placebo (1199.32/.34)

Nintedanib 100 Bid (1199.35)

Nintedanib 150 Bid (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

0 / 19Eligibility criteria met

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.