Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck Clinical Trial
Official title:
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
| Verified date | November 2015 |
| Source | Samsung Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 20 |
| Est. completion date | January 2017 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | response rate | 6months after patient enrollment | No |