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Head and Neck NeoplasmsPhase 2NCT02633800

Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

A Phase 2 study testing Patritumab, Cetuximab and Cisplatin in people with Head and Neck Neoplasms, run by Daiichi Sankyo at 34 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
Patritumab, Cetuximab and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
34 sitesin 7 countries
Study dates
22 Dec 2015to 21 Feb 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Has histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx, and larynx
  • Has or be willing to provide tumor tissue for testing
  • Has measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
  • Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Has adequate hematological function per protocol
  • Has adequate renal function per protocol
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  • Has adequate hepatic function per protocol
  • Agrees to use effective contraception while on the study and for 6-months after the end of the study
  • Provides written informed consent(s)

Who cannot join

  • Has left ventricular ejection fraction (LVEF) <50%
  • Had prior epidermal growth factor receptor (EGFR) targeted regimen
  • Had prior anti-human epidermal growth factor receptor 3 (anti-HER3) therapy
  • Had prior chemotherapy for recurrent/metastatic disease
  • Had anti-cancer therapy between biopsy and submission of sample
  • 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 ≥ 2 years
Show all 12Show fewer
  • Has known history of brain metastases or active brain metastases
  • Has uncontrolled hypertension
  • Has clinically significant electrocardiograph (ECG) findings
  • Had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or arrhythmia requiring medication
  • Had platinum-containing drug therapy with radiotherapy less than 6 months before study drug treatment
  • Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment

Trial locations and contacts

34 sites in 7 countries.

34 sites in 7 countries

France10 sites

  • Institut de Cancerologie de l'Ouest

    Angers, 49055

  • Centre Hospitalier de Bordeaux - Hôpital Saint André

    Bordeaux, 33075

  • Hopital Croix-Rousse

    Lyon, 69004

  • Centre Leon Berard

    Lyon, 69373

  • CHU Hopital de la Timone

    Marseille, 13005

  • Hopital Saint Joseph

    Marseille, 13008

  • Centre de Cancerologie du Grand Montpellier

    Montpellier, 34070

  • Institut Curie

    Paris, Cedex, 75248

  • Institut de Cancerologie de l'Ouest

    Saint-Herblain, 44805

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

United Kingdom7 sites

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2PG

  • Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

    London, SE1 7EH

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • The Shrewsbury and Telford Hospital NHS Trust

    Shrewsbury, SY3 8XQ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

Hungary5 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum

    Debrecen, 4032

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, 6000

  • Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • Josa Andras Oktatokorhaz

    Nyíregyháza, 4400

Other trials in Hungary

Belgium3 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Univeristair Ziekenhuis Antwerpen

    Edegem, 2650

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Germany3 sites

  • Charite Universitatsmedizin Berlin

    Berlin, 12200/12203

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinikum der Universitat Munchen

    München, 81377

Other trials in Germany

Poland3 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796

  • Przychodnia Lekarska "KOMED"

    Konin, 62-500

  • Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi

    Lodz, 93-513

Other trials in Poland

Romania3 sites

  • Medisprof SRL

    Cluj-Napoca, 400058

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200347

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

Other trials in Romania

About this study

Official title: Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

Read the detailed description

Main objective of the trial:

The main objective of the trial is to evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.

Being tested
Patritumab, Cetuximab, Cisplatin, Carboplatin, Placebo
Keywords
Squamous cell cancer of the head and neck, Squamous cell carcinoma, Head and neck cancer, Neoplasms by site
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PatritumabDrug

    Also called U3-1287

    Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks

  • CetuximabDrug

    Cetuximab 400 mg/mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly

  • CisplatinDrug

    Also called Platinum-based therapy

    Cisplatin at 100 mg/m^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles

  • CarboplatinDrug

    Also called Platinum-based therapy

    Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles

  • PlaceboDrug

    Placebo to match patritumab

Study groups in NCT02633800
Study groupRoleWhat they receive
PatritumabExperimentalAll participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Receives: Drug: Patritumab; Drug: Cetuximab; Drug: Cisplatin; Drug: Carboplatin
PlaceboPlacebo comparatorAll participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Receives: Drug: Cetuximab; Drug: Cisplatin; Drug: Carboplatin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population

    PFS is defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever comes first.

    Median PFS is from Kaplan-Meier analysis. Confidence interval (CI) for median was computed using Brookmeyer-Crowley method.

    Measured: from Day 0 to end of active study (study termination) - within 12 months

Secondary outcomes (2)

  1. Median Overall Survival

    Overall survival (OS) is defined as the time from the date of randomization to death due to any cause

    Measured: at approximately 25 months

  2. Percentage of Participants With Best Overall Response

    Best overall response rate (ORR) is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR)

    Measured: at approximately 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2015 (estimated)
  2. Study start22 Dec 2015
  3. Primary completion11 Jan 2018
  4. Study completion21 Feb 2018

Why it stopped: Trial was terminated by sponsor due to lack of efficacy.

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02633800
Sponsor's protocol ID
U31287-A-U203
Other IDs
2015-002222-40, 2015
Status last verified
Dec 2018
First submitted
15 Dec 2015
Last updated
7 Jan 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

Publications

  • Barber PR, Mustapha R, Flores-Borja F, Alfano G, Ng K, Weitsman G, Dolcetti L, Suwaidan AA, Wong F, Vicencio JM, Galazi M, Opzoomer JW, Arnold JN, Thavaraj S, Kordasti S, Doyle J, Greenberg J, Dillon MT, Harrington KJ, Forster M, Coolen ACC, Ng T. Predicting progression-free survival after systemic therapy in advanced head and neck cancer: Bayesian regression and model development. Elife. 2022 Dec 23;11:e73288. doi: 10.7554/eLife.73288.

    PubMed 36562609

  • Forster MD, Dillon MT, Kocsis J, Remenar E, Pajkos G, Rolland F, Greenberg J, Harrington KJ. Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. Eur J Cancer. 2019 Dec;123:36-47. doi: 10.1016/j.ejca.2019.08.017. Epub 2019 Oct 21.

    PubMed 31648099

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Patritumab, Cetuximab and Cisplatin in people with Head and Neck Neoplasms, run by Daiichi Sankyo at 34 sites in 7 countries.

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 12 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 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in France, United Kingdom, Hungary, Belgium, Germany and 2 more countries. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population (time frame: from Day 0 to end of active study (study termination) - within 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02633800, which also lists 2 linked publications.

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 7 Jan 2019.

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