Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nintedanib in Patients With Advanced Esophagogastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234596
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
This is a phase II study of Nintedanib in patients with metastatic or recurrent esophagogastric cancer. The goal of the study is to evaluate the efficacy of Nintedanib, an orally available triple kinase inhibitor targeting the receptors of the vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), and fibroblast growth factor (FGF) receptor pathways.

Condition or disease Intervention/treatment Phase
Esophagogastric Adenocarcinoma Drug: Nintedanib Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Nintedanib in Patients With Advanced Esophagogastric Cancer
Actual Study Start Date : September 4, 2014
Actual Primary Completion Date : April 22, 2020
Actual Study Completion Date : April 22, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nintedanib Drug: Nintedanib
Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.




Primary Outcome Measures :
  1. 6-month progression-free survival (PFS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. objective response rate [ Time Frame: 3 years ]
    defined as both complete response (CR) and partial response (PR), as measured by RECIST response criteria.

  2. Toxicities [ Time Frame: 3 years ]
    The severity of adverse event should be classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Pathologically or cytologically MSKCC confirmed esophagogastric adenocarcinoma.
  • Metastatic diseases measurable or evaluable on a CT or MRI scan according to RECIST 1.1 criteria. Locally recurrent disease that is not amenable to potentially curative surgery or radiation therapy is also allowed. Lesions must be ≥10mm in size. Recurrent or metastatic disease within a prior radiation field is acceptable as long as the disease has progressed in the radiation field by RECIST criteria.
  • Patients are allowed to have had a maximum of 1 prior chemotherapy regimen for metastatic disease. Patients are allowed to have a maximum of two prior regimens if they previously received neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for their initial localized disease.
  • Patients aged 18 years or older.
  • Life expectancy of at least 6 months.
  • Karnofsky Performance Status (KPS) performance score ≥ 70%.
  • Patients must be able to reliably take and swallow oral medications.
  • Patients with prior deep vein thrombosis (DVT) or pulmonary embolism (PE) currently on anticoagulation regimen will be permitted.
  • Adequate bone marrow, liver, and renal function as assessed by the following:
  • Hemoglobin ≥ 9.0 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3.
  • Platelet count ≥ 100,000/mm3.
  • Total bilirubin within normal limits, 0-1 mg/dL.
  • AST and ALT< 1.5 times ULN. (For patients with liver involvement: AST and ALT≤ 2.5 ULN).
  • International normalized ratio (INR) < 2, prothrombin time (PT) < 20 sec, and partial thromboplastin time (PTT) < 55 sec .
  • Creatinine < 1.5 x the ULN or GFR<45 ml/min.

Exclusion Criteria:

  • HER-2 positive esophagogastric cancer. Patients with unknown HER2 status are permitted.
  • Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating esophagogastric cancer. Last prior therapy must have been completed at least 2 weeks (14 days) prior to starting Nintedanib.
  • Concurrent radiotherapy is not permitted for disease progression on treatment on protocol. However, symptomatic treatment for pre-existing non-target lesions would be allowed with approval from the principal investigator.
  • Prior treatment with VEGFR inhibitor.
  • Brain metastases or leptomeningeal disease.
  • History of arterial thromboembolic (arterial blood clot) or hemorrhagic event with the exception of patients with pulmonary embolism stable on an anticoagulation regimen.
  • Patients with a cerebrovascular accident or transient ischemic attack within the past six months.
  • Patients on warfarin for any reason.
  • Patient with known pre-existing interstitial lung disease.
  • History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, New York Heart Association (NYHA) functional classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 month prior to the study entry.
  • Patients with history of proteinuria grade ≥ 2.
  • Women of childbearing potential (WOCBP), or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial and for at least three months after the end of active therapy.
  • Women who are pregnant or breast-feeding. Persistence of clinically relevant therapy related toxicity from previous chemotherapy and/or radiotherapy. This does not include hemoglobin or other hematologic or laboratory criteria, as long as eligibility criteria are met
  • Other malignancies within the past 5 years other than non-melanoma superficial skin cancer or carcinoma in situ of the cervix.
  • Concurrent medical conditions or injury which may increase the risk of toxicity, including ongoing or active infection, history of significant bleeding disorder unrelated to cancer (congenital bleeding disorders, acquired bleeding disorders within one year), history of HIV-positive, or active or chronic hepatitis C and/or B infection.
  • Known or suspected active drug or alcohol abuse.
  • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug. Patients who are unable to orally swallow the study medication.
  • Known hypersensitivity to trial drug.

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): NCT02234596


Locations
Layout table for location information
United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
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 1275 York Avenue
New York, New York, United States, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Yelena Janjigian, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02234596    
Other Study ID Numbers: 14-094
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Nintedanib
14-094
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action