Squamous Cell Carcinoma of the Head and NeckPhase 1NCT02350712
Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer
A Phase 1 study testing Patritumab, Cetuximab and Cisplatin in people with Squamous Cell Carcinoma of the Head and Neck, run by Daiichi Sankyo at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Patritumab, Cetuximab and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Dec 2014to Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed recurrent disease or metastatic SCCHN originating from the oral cavity, oropharynx, hypopharynx, and larynx
- Has documented disease recurrence following prior treatment
- Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Has adequate hematological function, per protocol
- Has adequate renal function, per protocol
- Has adequate hepatic function, per protocol
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- Has prothrombin time (PT) or partial thromboplastin time (PTT) within 1.5 x upper limit of normal (ULN)
- Has a negative serum pregnancy test performed within 14 days prior to enrollment (where required by local regulations, test may be required within 72 hours prior to enrollment), if a woman of child-bearing potential
- Agrees to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last study dose received, if of child-bearing potential
- Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Has left ventricular ejection fraction (LVEF) < 50%
- Has received prior epidermal growth factor receptor (EGFR) targeted regimen
- Has received prior anti-HER2, anti-HER3, or anti-HER4 therapy
- Has received prior treatment for recurrent/metastatic disease
- Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- Has known history of and active brain metastases
Show all 17Show fewer
- Has uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg)
- Has clinically significant electrocardiogram (ECG) changes
- Has had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association >Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- Had platinum-containing drug therapy/chemotherapy with radiotherapy < 6 months before study drug treatment
- Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment.
- Participated in clinical drug trials within 4 weeks before study drug treatment or is currently participating in other investigational procedures
- Has uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, active hepatitis B or C infection, or is undergoing medical treatment for infection
- Has uncontrolled type 1 or 2 diabetes mellitus
- Has known hypersensitivity or allergic reaction against any of the components of the trial treatment
- Is pregnant, breastfeeding, or unwilling/unable to use acceptable contraception
- Has psychological, social, familial, or geographical factors that would interfere with study participation or follow up
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University College London Hospital
London, NW1 2BU
The Royal Marsden Hospital
London, SW3 6JJ
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: An Open Label, Phase 1B Safety Evaluation of Patritumab (U31287) in Combination With Cetuximab Plus Platinum Containing Therapy In Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will show how safe and how well tolerated patritumab is when these medications are given together.
Read the detailed description
The trial will be performed in two "phases" (Periods):
Period 1: Initial phase in which the recommended phase 2 dose (RP2D) is determined
Period 2: Extension phase in which participants who are deriving benefit (stable disease or better) will have the opportunity to continue treatment at the discretion of the Investigator
- Being tested
- Patritumab, Cetuximab, Cisplatin, Carboplatin
- Keywords
- Recurrent or metastatic squamous cell carcinoma of the head and neck, SCCHN
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatritumabDrug
Also called U3-1287, Monoclonal antibody
Patritumab initial loading dose is 18 mg/kg IV over 60 minutes, followed in Cycle 2 and beyond with a maintenance dose of 9 mg/kg IV over 60 minutes (+/- 10 minutes) every 3 weeks. Infusion time can be extended to a maximum of 120 minutes for participants unable to tolerate the 60-minute infusion.
CetuximabDrug
Also called Chemotherapy
Cetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly.
CisplatinDrug
Also called Chemotherapy, Platinum therapy
Cisplatin is given as an IV infusion, over 1 hour, 1 hour after the cetuximab infusion, every 3 weeks up to a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).
CarboplatinDrug
Also called Chemotherapy, Platinum therapy
Carboplatin is given as an IV-bolus, over 30-60 minutes, every 3 weeks, for a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).
| Study group | Role | What they receive |
|---|---|---|
| All Participants - Period 1 | Experimental | All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin) in Period 1 - Initial phase of the trial. Receives: Drug: Patritumab; Drug: Cetuximab; Drug: Cisplatin; Drug: Carboplatin |
| All Participants - Period 2 | Experimental | Participants deriving clinical benefit enter Period 2 - Extension phase, during which they continue to receive patritumab with cetuximab, but not platinum-based therapy. Receives: Drug: Patritumab; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants experiencing dose-limiting toxicities (DLTs)
DLTs are used to determine the maximum tolerated dose.
Measured: 6 months
Secondary outcomes (4)
Pharmacokinetic profile of serum patritumab
Cmax and AUC
Measured: 6 months
Pharmacokinetic profile of serum cetuximab
Cmax and AUC
Measured: 6 months
Percentage of participants with human anti-human antibody (HAHA) formation (anti-patritumab antibodies)
Measured: 6 months
Titer of HAHA formation (anti-patritumab antibodies)
A titer is a way of expressing concentration. Titer testing employs serial dilution to obtain approximate quantitative information from an analytical procedure that inherently only evaluates as positive or negative. The titer corresponds to the highest dilution factor that still yields a positive reading.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Team Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350712
- Sponsor's protocol ID
- U31287-A-U106
- Other IDs
- 2014-002445-22, 2014
- Status last verified
- Sep 2018
- First submitted
- 19 Jan 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1B Safety Evaluation of Patritumab (U31287) in Combination With Cetuximab Plus Platinum Containing Therapy In Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT02350712
- Acronym / sponsor ID
- U31287-A-U106
- Keywords
- Recurrent or metastatic squamous cell carcinoma of the head and neck, SCCHN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jan 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.
The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will show how safe and how well tolerated patritumab is when these medications are given together.
Detailed description
The trial will be performed in two "phases" (Periods):
Period 1: Initial phase in which the recommended phase 2 dose (RP2D) is determined
Period 2: Extension phase in which participants who are deriving benefit (stable disease or better) will have the opportunity to continue treatment at the discretion of the Investigator
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All Participants - Period 1 | Experimental | Drug: Patritumab, Drug: Cetuximab, Drug: Cisplatin, Drug: CarboplatinAll participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin) in Period 1 - Initial phase of the trial. |
| All Participants - Period 2 | Experimental | Drug: Patritumab, Drug: CetuximabParticipants deriving clinical benefit enter Period 2 - Extension phase, during which they continue to receive patritumab with cetuximab, but not platinum-based therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed recurrent disease or metastatic SCCHN originating from the oral cavity, oropharynx, hypopharynx, and larynx
- Has documented disease recurrence following prior treatment
- Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Has adequate hematological function, per protocol
- Has adequate renal function, per protocol
Key exclusion criteria (17 listed)
- Has left ventricular ejection fraction (LVEF) < 50%
- Has received prior epidermal growth factor receptor (EGFR) targeted regimen
- Has received prior anti-HER2, anti-HER3, or anti-HER4 therapy
- Has received prior treatment for recurrent/metastatic disease
- Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
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 |
|---|---|---|
| PatritumabAlso: U3-1287, Monoclonal antibodyPatritumab initial loading dose is 18 mg/kg IV over 60 minutes, followed in Cycle 2 and beyond with a maintenance dose of 9 mg/kg IV over 60 minutes (+/- 10 minutes) every 3 weeks. Infusion time can be extended to a maximum of 120 minutes for participants unable to tolerate the 60-minute infusion. | Drug | All Participants - Period 1, All Participants - Period 2 |
| CetuximabAlso: ChemotherapyCetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly. | Drug | All Participants - Period 1, All Participants - Period 2 |
| CisplatinAlso: Chemotherapy, Platinum therapyCisplatin is given as an IV infusion, over 1 hour, 1 hour after the cetuximab infusion, every 3 weeks up to a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion). | Drug | All Participants - Period 1 |
| CarboplatinAlso: Chemotherapy, Platinum therapyCarboplatin is given as an IV-bolus, over 30-60 minutes, every 3 weeks, for a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion). | Drug | All Participants - Period 1 |
Primary outcome
Percentage of participants experiencing dose-limiting toxicities (DLTs)
Time frame: 6 months
DLTs are used to determine the maximum tolerated dose.
4 secondary outcomes
Pharmacokinetic profile of serum patritumab
Time frame: 6 months
Pharmacokinetic profile of serum cetuximab
Time frame: 6 months
Percentage of participants with human anti-human antibody (HAHA) formation (anti-patritumab antibodies)
Time frame: 6 months
Titer of HAHA formation (anti-patritumab antibodies)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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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.
Global Team Leader study director
Daiichi Sankyo
3 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 Patritumab, Cetuximab and Cisplatin in people with Squamous Cell Carcinoma of the Head and Neck, run by Daiichi Sankyo at 3 sites in United Kingdom.
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 10 inclusion and 17 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: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants experiencing dose-limiting toxicities (DLTs) (time frame: 6 months). 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 11 Sep 2018.