Recurrent or Metastatic Salivary Gland Cancer of the Head and NeckPhase 2NCT02558387
Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
A Phase 2 study testing BIBF1120 in people with Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
- What is being tested?
- BIBF1120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- BIBF1120
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF1120Drug
Also called Nintedanib
Nintedanib will be given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BIBF1120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 6months after patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Salivary Gland Cancer of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-Ju Ahn, Samsung Medical Center
- Investigators
- Myung-Ju Ahn, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558387
- Sponsor's protocol ID
- 2013-120133
- Status last verified
- Nov 2015
- First submitted
- 22 Sep 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02558387
- Acronym / sponsor ID
- 2013-120133
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nintedanib arm | Experimental | Drug: BIBF1120Nintedanib 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBF1120Also: NintedanibNintedanib will be given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity. | Drug | Nintedanib arm |
Primary outcome
response rate
Time frame: 6months after patient enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Related trials for Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
Active, not recruitingPhase 2
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
Salivary Gland Neoplasms
RecruitingPhase 2
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma
Active, not recruitingPhase 3
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1
First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor
NSCLC Patients With EGFR Activating Mutation, Adenoid Cystic Carcinoma Metastatic
Active, not recruitingPhase 2
Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers
Locally Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung-Ju Ahn, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBF1120 in people with Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 6months after patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.