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

Primary Purpose

Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

BIBF1120

About this trial

This is an interventional treatment trial for Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nintedanib arm

Arm Description

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.

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

Full Information

NCT ID

NCT02558387

First Posted

September 22, 2015

Last Updated

November 18, 2015

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02558387

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nintedanib arm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

BIBF1120

Other Intervention Name(s)

Nintedanib

Intervention Description

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

Primary Outcome Measure Information:

Title

response rate

Time Frame

6months after patient enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myung-Ju Ahn, MD, PhD

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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