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Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis

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ClinicalTrials.gov Identifier: NCT02496585
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib in combination with steroids, has on the lungs. Furthermore, such treatments' side effects will be studied together with quality of life. In addition, the investigators would like to determine whether they can find markers in the blood which predict worsening lung injury.

Condition or disease Intervention/treatment Phase
Lung Cancer Lung Metastases Drug: Nintedanib Drug: Prednisone Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
Study Start Date : July 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Steroids

Arm Intervention/treatment
Experimental: Nintedanib + Prednisone
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).
Drug: Nintedanib
Other Name: BIBF 1120

Drug: Prednisone
Experimental: Placebo + Prednisone
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).
Drug: Prednisone
Other: Placebo



Primary Outcome Measures :
  1. Number of patients who are free from pulmonary exacerbations [ Time Frame: 12 months ]

    An acute exacerbation will be defined as (all criteria must be met):

    1. Unexplained worsening or development of cough, dyspnea, hypoxia, or pneumonitis lasting more than 4 days
    2. New or worsening diffuse pulmonary infiltrates on chest CT (with or without contrast) or new high resolution CT parenchymal abnormalities without significant pneumothorax or pleural effusion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically/cytologically proven primary thoracic or breast malignancy, lymphoma or lung metastases (which are not required to be biopsy-proven) treated with definitive intent at MSK
  • Prior treatment with thoracic radiotherapy completed >4 weeks and ≤ 9 months prior to enrollment
  • Radiographic evidence of radiation pneumonitis on a CT scan of the chest with or without contrast
  • Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to CTCAE version 4.0 criteria
  • Age≥18 years
  • KPS > 70%
  • Reduction of any acute toxicity from radiation treatment to grade 1
  • Written informed consent signed prior to entry into the study

Exclusion Criteria:

  • Current oral steroid use > 4 weeks prior to registration
  • Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy, except the following therapies which are permitted: Pembrolizumab, Nivolumab, Afatinib and all hormonal therapies.
  • Mean esophageal radiation dose >45 Gy
  • Diagnosis of diffuse radiation pneumonitis
  • Untreated or symptomatic brain metastases or leptomeningeal disease
  • Liver metastases
  • Other active malignancies requiring oncologic treatment (Note: non-melanoma skin cancer, superficial bladder cancer etc. are eligible)
  • Radiographic evidence of cavitary or necrotic tumor and local invasion of major blood vessels
  • Active chronic Hepatitis C and/or B infection
  • Gastrointestinal disorders that would interfere with drug absorption
  • AST > 1.5 x ULN, ALT>1.5 x ULN and Bilirubin > 1.5 x ULN
  • ≥ Grade 2 proteinuria, creatinine >1.5x ULN or GFR <45 ml/min
  • Other investigational therapy received within 8 weeks prior to screening visit
  • Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrollment1
  • Sexually active males not committing to birth control during the course of the study (except if their partner is not of childbearing potential)
  • Conditions that may affect the patient's ability to participate in this trial, e.g. known or suspected active alcohol or drug abuse
  • Inherited predisposition to bleeding or thrombosis, INR >2, PT and PTT >1.5x ULN
  • History of bleeding disorders or thrombotic events, e.g. hemorrhagic or thrombotic events within 12 months, clinically significant or tumor-related hemoptysis, active gastrointestinal bleeding or ulcers or major injuries or surgery
  • ANC < 1.5 K/mcL, Platelets < 100 K/mcL, Hemoglobin < 9.0 g/dl
  • Concomitant treatment with any of the following drugs: azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full dose anticoagulation (vitamin K antagonists, dabigatran, heparin, etc.), fibrinolysis and high dose anti-platelet therapy (ex. Plavix 150mg)^2 Myocardial infarction or unstable angina within 6 or 1 month of starting nintedanib treatment, respectively
  • Known inherited predisposition to thrombosis
  • Patient with a history of a thrombotic event within 12 months of starting nintedanib treatment
  • Known predisposition to bleeding
  • Patients with severe hepatic impairment
  • History of a gastrointestinal perforation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02496585


Contacts
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Contact: Andreas Rimner, MD 212-639-6025
Contact: Paul Paik, MD 646-888-4202

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Raymond Mak, MD    617-632-3591      
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Andreas Rimner, MD    212-639-6025      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andreas Rimner, MD    212-639-6025      
Contact: Jamie Chaft, MD    646-888-4545      
Principal Investigator: Andreas Rimner, MD         
Memorial Sloan Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Andreas Rimner, MD    212-639-6025      
Contact: Jamie Chaft, MD    646-888-4545      
Principal Investigator: Andreas Rimner, MD         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Andreas Rimner, MD    212-639-6025      
United States, Texas
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Daniel Gomez, MD    713-563-8446      
Principal Investigator: Daniel Gomez, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Boehringer Ingelheim
Investigators
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Principal Investigator: Andreas Rimner, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02496585     History of Changes
Other Study ID Numbers: 14-167
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
Nintedanib (BIBF 1120)
Prednisone
Radiation Pneumonitis

Additional relevant MeSH terms:
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Pneumonia
Radiation Pneumonitis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries
Prednisone
Nintedanib
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action