A Phase 1 interventional study of Patritumab and Cetuximab in Squamous Cell Carcinoma of the Head and Neck, sponsored by Daiichi Sankyo. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-11.
Sponsored by Daiichi Sankyo · Phase 1, Interventional, and Treatment
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.
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
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 15 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
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
Percentage of participants experiencing dose-limiting toxicities (DLTs)
DLTs are used to determine the maximum tolerated dose.
Time frame: 6 months
Pharmacokinetic profile of serum patritumab
Cmax and AUC
Time frame: 6 months
Pharmacokinetic profile of serum cetuximab
Cmax and AUC
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)
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.
Time frame: 6 months
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Daiichi Sankyo