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Trial record 48 of 48 for:    Dovitinib

Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

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ClinicalTrials.gov Identifier: NCT02558387
Recruitment Status : Unknown
Verified November 2015 by Myung-Ju Ahn, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck Drug: BIBF1120 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : January 2017

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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.
Drug: BIBF1120
Nintedanib will be given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
Other Name: Nintedanib




Primary Outcome Measures :
  1. response rate [ Time Frame: 6months after patient enrollment ]


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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 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

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): NCT02558387


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Myung-Ju Ahn, MD, PhD Samsung Medical Center

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Responsible Party: Myung-Ju Ahn, MD, PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02558387     History of Changes
Other Study ID Numbers: 2013-120133
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Salivary Gland Neoplasms
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action