- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02558387
Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
Phase II Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck : a Multicentre Phase II Study
Recently, sorafenib which can target VEGFR and PDGFR demonstrated 13-16% of response rate in patients with recurrent/metastatic salivary gland cancers, suggesting that VEGFR and PDGFR might be important role in salivary gland cancers. Accordingly, several trials with various anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in salivary gland cancer are ongoing.
Nintedanib (BIBF1120) is a potent small molecule triple receptor tyrosine kinase inhibitor (PDGFR/ FGFR1-2 and VEGFR1-3). VEGFR-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. In vitro, the target receptors are all inhibited by nintedanib in low nanomolar concentrations. In in vivo nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg, leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts of a broad range of differing human tumors.
Based on this background, in this study, the investigators would like to conduct a phase II study of Nintedanib (BIBF 1120) in patients with recurrent or metastatic salivary gland cancer of the head and neck to evaluate efficacy and safety.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically proven salivary gland cancer of the head and neck (According to WHO classification, mucoepidermoid cancer, adenoid cystic carcinoma, or adenocarcinoma/salivary duct cancer are eligible)
- Recurrent or metastatic salivary gland cancer of the head and neck patients who failed one line of systemic chemotherapy
- age ≥ 18 years
- At least one measurable tumor lesion according to RECIST 1.1
- ECOG performance status 0-2
- Adequate hematologic function (absolute neutrophil count > 1,500/m/, platelets > 100,000/ml, haemoglobin > 9.0 g/dl), hepatic function (alanine transaminase/aspartate transaminase < 5 x ULN, total bilirubin < 1.5 x ULN), renal function (creatinine clearance > 45 ml/min)
- Written informed consent
Exclusion Criteria:
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment, or arrhythmia
- Hemorrhagic or thromboembolic events in the past 6 months
- Major injuries in the 10 days prior to start of the study
- Patients with post-obstructive pneumonia or uncontrolled serious infection
- Pregnant or nursing women
- Uncontrolled symptomatic brain metastasis
- Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, and well treated thyroid cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nintedanib arm
Nintedanib has never been applied to salivary gland cancer.
Nintedanib was given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
|
Nintedanib will be given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response rate
Time Frame: 6months after patient enrollment
|
6months after patient enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Myung-Ju Ahn, MD, phD, Samsung Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Stomatognathic Diseases
- Mouth Diseases
- Salivary Gland Diseases
- Mouth Neoplasms
- Head and Neck Neoplasms
- Recurrence
- Salivary Gland Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Nintedanib
Other Study ID Numbers
- 2013-120133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
-
Fox Chase Cancer CenterWithdrawnTongue Cancer | Recurrent Metastatic Squamous Neck Cancer With Occult Primary | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous... and other conditionsUnited States
-
OSI PharmaceuticalsCompletedLocally Recurrent or Metastatic Cancer of the Head and Neck | Must Have Failed First-Line TherapyUnited States
-
Abramson Cancer Center of the University of PennsylvaniaCompletedHead and Neck Cancer | Recurrent Metastatic Squamous Neck Cancer With Occult Primary | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent... and other conditionsUnited States
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)CompletedTongue Cancer | Recurrent Metastatic Squamous Neck Cancer With Occult Primary | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Metastatic Squamous Neck Cancer With Occult Primary | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma... and other conditionsCanada
-
Ontario Clinical Oncology Group (OCOG)Novartis PharmaceuticalsCompletedRecurrent Adenoid Cystic Carcinoma of the Salivary Glands | Metastatic Adenoid Cystic Carcinoma of the Salivary Glands | Salivary Gland Cancers | ACCCanada
-
National Cancer Institute (NCI)Southwest Oncology GroupCompletedRecurrent Salivary Gland Cancer | Recurrent Adenoid Cystic Carcinoma of the Oral Cavity | Stage III Adenoid Cystic Carcinoma of the Oral Cavity | Stage III Salivary Gland Cancer | Stage IV Adenoid Cystic Carcinoma of the Oral Cavity | Stage IV Salivary Gland Cancer | Salivary Gland Adenoid Cystic...United States
-
University Health Network, TorontoActive, not recruitingSalivary Gland Cancer | Metastatic | Recurrent | AdvancedCanada
-
BioAtla, Inc.RecruitingHead and Neck Cancer | Metastatic Cancer | Squamous Cell Carcinoma of Head and Neck | Recurrent Squamous Cell Carcinoma of the Head and Neck | Metastatic Squamous Cell Carcinoma of the Head and NeckUnited States
-
Vanderbilt-Ingram Cancer CenterBoehringer Ingelheim; National Comprehensive Cancer NetworkWithdrawnSquamous Cell Carcinoma | Recurrent Squamous Cell Carcinoma of the Head or Neck | Metastatic Squamous Cell Carcinoma of the Head or Neck
Clinical Trials on BIBF1120
-
Boehringer IngelheimCompleted
-
Ulrik LassenUniversity of Copenhagen; Boehringer IngelheimCompleted
-
AHS Cancer Control AlbertaBoehringer Ingelheim; Cross Cancer InstituteWithdrawnSmall Cell Lung Cancer | Platinum-sensitiveCanada
-
National Taiwan University HospitalUnknownUrothelial CarcinomaTaiwan
-
University Hospital MuensterBoehringer IngelheimUnknownAcute Myeloid LeukemiaGermany
-
European Organisation for Research and Treatment...CompletedDifferentiated Thyroid Cancer (DTC) | Medullary Thyroid Cancer (MTC)France, Belgium, Denmark, Italy, Netherlands, Germany, Poland, Spain, United Kingdom
-
European Organisation for Research and Treatment...Boehringer IngelheimTerminatedSarcoma, Soft TissueFrance, Belgium, Poland, Spain, Lithuania, Netherlands, United Kingdom
-
University of Alabama at BirminghamBoehringer IngelheimCompletedRenal Cell Carcinoma | Non-squamous Non-small Cell Lung Cancer | Cervical Carcinoma | Colorectal Adenocarcinoma | Platinum-refractory Ovarian CarcinomaUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteActive, not recruitingNon Small Cell Lung Cancer | Non Small Cell Lung Cancer Metastatic | Lung Cancer, Nonsmall CellUnited States
-
Boehringer IngelheimCompletedPulmonary FibrosisArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Russian Federation, South Africa, Spain, Taiwan and more