Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer

NCT02350712 | Completed Phase 1

• 2 other identifiers: U31287-A-U1062014-002445-22
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Recurrent or metastatic squamous cell carcinoma of the head and neck; SCCHN

Outcome Measures

Primary Outcomes (1)

• Percentage of participants experiencing dose-limiting toxicities (DLTs)

  DLTs are used to determine the maximum tolerated dose.

  6 months

Secondary Outcomes (4)

• Pharmacokinetic profile of serum patritumab

  6 months

• Pharmacokinetic profile of serum cetuximab

  6 months

• Percentage of participants with human anti-human antibody (HAHA) formation (anti-patritumab antibodies)

  6 months

• Titer of HAHA formation (anti-patritumab antibodies)

  6 months

Study Arms (2)

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.

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.

Drug: Patritumab; Drug: Cetuximab

Interventions

Patritumab DRUG

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.

Also known as: U3-1287, Monoclonal antibody

All Participants - Period 1; All Participants - Period 2

Cetuximab DRUG

Cetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly.

Also known as: Chemotherapy

All Participants - Period 1; All Participants - Period 2

Cisplatin DRUG

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).

Also known as: Chemotherapy, Platinum therapy

All Participants - Period 1

Carboplatin DRUG

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).

Also known as: Chemotherapy, Platinum therapy

All Participants - Period 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (3)

The Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

University College London Hospital

London, NW1 2BU, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Recurrence

Interventions

patritumab; Antibodies, Monoclonal; Cetuximab; Drug Therapy; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Global Team Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 30, 2015
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

GB (3)