NCT02558387

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

September 22, 2015

Last Update Submit

November 18, 2015

Conditions

Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

  • response rate

    6months after patient enrollment

Study Arms (1)

Nintedanib arm

EXPERIMENTAL

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

Interventions

BIBF1120DRUG

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

Also known as: Nintedanib
Nintedanib arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Recurrence

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Myung-Ju Ahn, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 24, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2016

Study Completion

January 1, 2017

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

KR(1)