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 |
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Recruitment Status :
Completed
First Posted : July 14, 2015
Last Update Posted : April 16, 2024
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Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 33 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 |
| Actual Study Start Date : | July 8, 2015 |
| Actual Primary Completion Date : | April 12, 2024 |
| Actual Study Completion Date : | April 12, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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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).
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Drug: Nintedanib
Other Name: BIBF 1120 Drug: Prednisone |
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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).
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Drug: Prednisone Other: Placebo |
Primary Outcome Measures :
- 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):
- Unexplained worsening or development of cough, dyspnea, hypoxia, or pneumonitis lasting more than 4 days
- 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
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital (Data Collection Only) | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New Jersey | |
| Memorial Sloan Kettering Cancer Center at Basking Ridge | |
| Basking Ridge, New Jersey, United States, 07920 | |
| Memorial Sloan Kettering Monmouth | |
| Middletown, New Jersey, United States, 07748 | |
| Memorial Sloan Kettering Bergen | |
| Montvale, New Jersey, United States, 07645 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center @ Suffolk | |
| Commack, New York, United States, 11725 | |
| Memorial Sloan Kettering Westchester | |
| Harrison, New York, United States, 10604 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Memorial Sloan Kettering at Mercy Medical Center | |
| Rockville Centre, New York, United States | |
| Memorial Sloan Kettering Nassau | |
| Uniondale, New York, United States, 11553 | |
| United States, Pennsylvania | |
| Lehigh Valley Health Network (Data Collection Only) | |
| Allentown, Pennsylvania, United States, 18103 | |
| United States, Texas | |
| MD ANDERSON CANCER CENTER (Data Collection Only) | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Myriad Genetic Laboratory (Data or Specimen Analysis Only) | |
| Salt Lake City, Utah, United States, 84108 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Boehringer Ingelheim
Investigators
| Principal Investigator: | Zachary Moore, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02496585 |
| Other Study ID Numbers: |
14-167 |
| First Posted: | July 14, 2015 Key Record Dates |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | April 2024 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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Nintedanib (BIBF 1120) Prednisone Radiation Pneumonitis |
Additional relevant MeSH terms:
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Pneumonia Radiation Pneumonitis Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases 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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |