Head and Neck CancerPhase 1NCT03246854
A Study of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer
A Phase 1 study testing DBPR112 in people with Head and Neck Cancer and NSCLC, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
Trial summary
The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR mutated lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer, NSCLC
- What is being tested?
- DBPR112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesTaiwan
- Study dates
- 18 Jul 2017to 4 Aug 2018
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- Age from ≥18 to ≤70 years
- Life expectancy >12 weeks per investigator's judgement
- Squamous cell carcinoma of head and neck that has failed prior standard therapy for metastatic disease or advanced EGFR-mutated NSCLC that has failed prior standard therapy including at least one anti EGFR TK inhibitor
- Non-measurable but evaluable disease, or measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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- Adequate blood and organ function
- Male and female patients must agree to use contraception while on study and for 90 days after the last dose of DBPR112
- Aspartate aminotransferase/ALT <3 X ULN if no metastasis, and AST/ALT <5 X ULN in presence of metastasis
Who cannot join
- History of allergic reactions to any component of DBPR112
- History of unstable central nervous system (CNS) metastases or seizure disorder related to the malignancy; however, those patients who were treated for prior CNS metastases and who are asymptomatic may participate in the study
- History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia
- Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 28 days for chemotherapeutics and targeted agents, or 5 half-lives for proteins, whichever is longer, before the first dose of DBPR112
- Significant surgical intervention within 21 days of the first dose of DBPR112 or with ongoing postoperative complications
- Chronic skin condition that requires prescribed oral or intravenous treatment
Show all 25Show fewer
- History of severe rash that required discontinuation of prior EGFR targeted therapy
- History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapy
- Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 or equivalent
- Insufficient organ function as indicated by the following parameters
- Absolute neutrophil count (ANC) <1,500 /µL
- Platelets <100,000 /µL
- Hemoglobin <10 g/dL
- Serum creatinine >1.5 X ULN
- Serum total bilirubin >1.5 X ULN
- Aspartate aminotransferase/ALT >3 X ULN if no metastasis, AST/ALT >5 X ULN in presence of metastasis
- International normalized ratio or prothrombin time >1.5 X ULN
- Known history of human immunodeficiency virus (HIV)1 or 2
- Active clinically significant infection requiring systemic therapy
- Positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)
- Child-Pugh B \& C stage liver disease or liver function impairment
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of DBPR112 hazardous or obscure the interpretation of toxicity or AEs
- Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses that would preclude the absorption of DBPR112, which is an oral agent
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei, 10048
Taipei Medical University Hospital
Taipei, 110
About this study
Official title: Phase I, Open-Label, Multiple Dose, Dose-Finding and Expansion Clinical Study to Assess the Safety, Pharmacokinetics, and Efficacy of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer
The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR mutated lung cancer.
Read the detailed description
This is a Phase I, multi-center, open-label, first-in-human study to determine the MTD and RP2D of DBPR112 and to assess the safety, tolerability and PK of DBPR112 in Asian patients. Patients with non-small cell cancer (NSCLC) who have progressed following prior therapy with an epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor or in patients with squamous cell cancer of head and neck (SCCHN) who have progressed following prior standard therapy will be selected. Approximately 24 to 30 patients will be enrolled in this study as out patients/inpatients, in 2 study centers in Taiwan.
- Conditions
- Head and Neck Cancer, NSCLC
- Being tested
- DBPR112
- Keywords
- DBPR112, EGFR mutated NSCLC, squamous cell cancer of head and neck, maximum tolerated dose, recommended Phase 2 dose
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBPR112Drug
DBPR112 hard gelatin capsule solid dosage formulation; strength: 25 mg, 100 mg.
| Study group | Role | What they receive |
|---|---|---|
| DBPR112 | Experimental | Not described Receives: Drug: DBPR112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: up to 22 months
Area Under the Plasma Concentration-Time Curve (AUC from 0 to infinity)
Measured: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
Observed Maximum Plasma Concentration (Cmax)
Measured: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
Time of Maximum Plasma Concentration (tmax)
Measured: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
Secondary outcomes (2)
Incidence and intensity of Adverse Events and Serious Adverse Events as a measure of safety
Measured: Adverse events were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.
Preliminary antitumor activity of DBPR112 in patients with solid tumors
Measured: The tumor responses were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start18 Jul 2017
- Primary completion4 Aug 2018
- Study completion4 Aug 2018
Why it stopped: No more funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246854
- Sponsor's protocol ID
- DBPR112-101
- Status last verified
- Oct 2019
- First submitted
- 7 Jul 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label, Multiple Dose, Dose-Finding and Expansion Clinical Study to Assess the Safety, Pharmacokinetics, and Efficacy of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer
- ClinicalTrials.gov ID
- NCT03246854
- Acronym / sponsor ID
- DBPR112-101
- Conditions
- Head and Neck Cancer, NSCLC
- Keywords
- DBPR112, EGFR mutated NSCLC, squamous cell cancer of head and neck, maximum tolerated dose, recommended Phase 2 dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 4 Aug 2018 (actual)
- Study completion
- 4 Aug 2018 (actual)
- First posted
- 11 Aug 2017 (actual)
- 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.
The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR mutated lung cancer.
Detailed description
This is a Phase I, multi-center, open-label, first-in-human study to determine the MTD and RP2D of DBPR112 and to assess the safety, tolerability and PK of DBPR112 in Asian patients. Patients with non-small cell cancer (NSCLC) who have progressed following prior therapy with an epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor or in patients with squamous cell cancer of head and neck (SCCHN) who have progressed following prior standard therapy will be selected. Approximately 24 to 30 patients will be enrolled in this study as out patients/inpatients, in 2 study centers in Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBPR112 | Experimental | Drug: DBPR112 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patients
- Age from ≥18 to ≤70 years
- Life expectancy >12 weeks per investigator's judgement
- Squamous cell carcinoma of head and neck that has failed prior standard therapy for metastatic disease or advanced EGFR-mutated NSCLC that has failed prior standard therapy including at least one anti EGFR TK inhibitor
- Non-measurable but evaluable disease, or measurable disease per RECIST 1.1
Key exclusion criteria (25 listed)
- History of allergic reactions to any component of DBPR112
- History of unstable central nervous system (CNS) metastases or seizure disorder related to the malignancy; however, those patients who were treated for prior CNS metastases and who are asymptomatic may participate in the study
- History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia
- Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 28 days for chemotherapeutics and targeted agents, or 5 half-lives for proteins, whichever is longer, before the first dose of DBPR112
- Significant surgical intervention within 21 days of the first dose of DBPR112 or with ongoing postoperative complications
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 |
|---|---|---|
| DBPR112DBPR112 hard gelatin capsule solid dosage formulation; strength: 25 mg, 100 mg. | Drug | DBPR112 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: up to 22 months
Area Under the Plasma Concentration-Time Curve (AUC from 0 to infinity)
Time frame: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
Observed Maximum Plasma Concentration (Cmax)
Time frame: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
Time of Maximum Plasma Concentration (tmax)
Time frame: For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.
2 secondary outcomes
Incidence and intensity of Adverse Events and Serious Adverse Events as a measure of safety
Time frame: Adverse events were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.
Preliminary antitumor activity of DBPR112 in patients with solid tumors
Time frame: The tumor responses were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.
Results and safety
The study was stopped early (reason given: No more funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DBPR112 in people with Head and Neck Cancer and NSCLC, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
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 9 inclusion and 25 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: stopped early, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No more funding). 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?
Maximum Tolerated Dose (MTD) (time frame: up to 22 months). The study lists 4 primary outcomes in all. 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 17 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.