Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
NCT ID: NCT02558387
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2014-11-30
2017-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
BIBF1120
Nintedanib will be given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
Interventions
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BIBF1120
Nintedanib will be given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Myung-Ju Ahn
MD, PhD
Principal Investigators
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Myung-Ju Ahn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2013-120133
Identifier Type: -
Identifier Source: org_study_id