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

Head and Neck Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02633800
• Other study ID #: U31287-A-U203
• Secondary ID: 2015-002222-40
• Status: Terminated
• Phase: Phase 2
• Start date: December 22, 2015
• Est. completion date: February 21, 2018

Study information

• Verified date: December 2018
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: February 21, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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)

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Drug:
• Patritumab
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
• Cetuximab
Cetuximab 400 mg/mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly
• Cisplatin
Cisplatin at 100 mg/m^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
• Carboplatin
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
• Placebo
Placebo to match patritumab

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
Belgium	Univeristair Ziekenhuis Antwerpen	Edegem
Belgium	UZ Leuven	Leuven
France	Institut de Cancerologie de l'Ouest	Angers cedex 02
France	Centre Hospitalier de Bordeaux - Hôpital Saint André	Bordeaux
France	Centre Leon Berard	Lyon
France	Hopital Croix-Rousse	Lyon
France	CHU Hopital de la Timone	Marseille
France	Hopital Saint Joseph	Marseille
France	Centre de Cancerologie du Grand Montpellier	Montpellier
France	Institut Curie	Paris	Cedex
France	Institut de Cancerologie de l'Ouest	Saint-Herblain Cedex
France	Gustave Roussy	Villejuif
Germany	Charite Universitatsmedizin Berlin	Berlin
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Klinikum der Universitat Munchen	München
Hungary	Orszagos Onkologiai Intezet	Budapest
Hungary	Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum	Debrecen
Hungary	Bacs-Kiskun Megyei Korhaz	Kecskemet
Hungary	Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc
Hungary	Josa Andras Oktatokorhaz	Nyíregyháza
Poland	Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy	Bydgoszcz
Poland	Przychodnia Lekarska "KOMED"	Konin
Poland	Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi	Lodz
Romania	Medisprof SRL	Cluj-Napoca
Romania	Centrul de Oncologie Sfantul Nectarie	Craiova
Romania	Institutul Regional de Oncologie Iasi	Iasi
United Kingdom	Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	University College London Hospitals NHS Foundation Trust - University College Hospital	London
United Kingdom	Weston Park Hospital	Sheffield
United Kingdom	The Shrewsbury and Telford Hospital NHS Trust	Shrewsbury
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from Day 0 to end of active study (study termination) - within 12 months
Secondary	Median Overall Survival	Overall survival (OS) is defined as the time from the date of randomization to death due to any cause	at approximately 25 months
Secondary	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)	at approximately 22 months